You should be worried about pharmaceutical ethics: except when it comes to vaccines

In just a few short days the panic of measles has died down to barely a murmur in the news. The baby named Gryffin, who mother incited mass panic with her social media rant (and whose grandfather Alan Hibben is apparently a Canadian pharmaceuticals bigwig, oh well) has tested negative, predictably, and is presumably doing fine. Other infected individuals have apparently gone off into the sunset to convalesce uneventfully, since we haven't heard a damned thing about how they've fared since then; it's as if no one cares anymore (unless they die, of course).

Meanwhile, a few other interesting articles have surfaced (some old, some new) that haven't been getting the attention they should in light of the heated arguments and loss of friendships over whether to vaccinate or not. One such article was posted by Huffington Post Canada, who seems to be drinking less KoolAid over the vaccine debate than their American counterpart: "Merck has some explaining to do over its MMR vaccine claims."  Yes, yes they do have some "explaining" to do: but will they?

The article, originally published in September, leaves me wondering: has anyone followed up on this situation and whistle blower claims - which state that:

"It [Merck] "failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing."

In an additional lawsuit, Merck came under fire for not only monopolizing the market on their mumps vaccine, but selling an overpriced product that was ineffective as well. The suit contends that Merck predicted a mumps outbreak would occur - and it did - especially in highly vaccinated populations both in 2006 and in 2009-2010.

And only what, five years later, we're hearing about this. After assuming "I'm sure they've all been vaccinated, you need to get vaccinated!" over and over again. Well, what if they were? "Oh, sometimes that happens, they're not 100 percent guaranteed." I'm sure it's never because the manufacturer knew they were selling a defective product, right? "Oh, you're such a conspiracy theorist!"

I find it pretty crappy that American news outlets didn't pick this up and trounce it all over the place. There is a virtual treasure trove of articles about ethics violations and conflict of interest between drug makers and studies, all from perfectly reputable sources that are trusted by most Americans, and yet, here we are. Still calling non-vaccinating parents "stupid" and expecting them to actually trust the same companies and regulatory bodies that are fudging numbers, touting flawed or seriously questionable studies when it comes to other medicines on the market. But that study that proved vaccines cause autism? Yeah, that one was debunked. So get over it.

For the record, I vaccinated my kids. I think one of them still needs another dose of varicella (whoops! eye roll) and if it were up to me or I had the energy to fight it, I'd probably say screw it and we'd proceed as normal. I am increasingly skeptical of vaccines, though; not because of autism, or Jenny McCarthy (gag) but because of stuff like this: that I'm supposed to question and be afraid of the ethics violations of drug companies and the FDA, just as long as it doesn't come to vaccines. Okay, that makes perfect sense.

It seems that when parents genuinely do have concerns about these companies or the far reach of the FDA when it comes to vaccinations, they're belittled, criticized, sworn at, and practically threatened with death or jail: they should die, their kids should die, they should be jailed, blah blah blah. I've heard it all. What they don't realize during their foaming-at-the-mouth rant is that they sound as bad as people who claim vaccines killed the dinosaurs (or whatever ridiculously implausible anti-vaccine rant you can think of). Besides, all that's been done before: during the American smallpox epidemic, refusers were often vaccinated at gun point or jailed because of their beliefs. And even then, they realized that duh, we can't really send a government-employed official out to hunt you down and vaccinate you against your will, so they stopped doing it by force (at least if you're a civilian). (Although there are some reports that claim people in Malawi were recently held at gunpoint during vaccination campaigns, but I can't corroborate that yet.)

Forbes Magazine - whose articles on vaccines often read like paid propaganda, in my opinion - warns us all to be wary of the FDA and the recall of generic Wellbutrin's 300 mg dosage, a drug primarily used for depression and smoking cessation. It was found that increasing numbers of patients were reporting drug ineffectiveness with the 300 mg dosage, and patient advocacy groups were ignored when they gathered hundreds of complaints from the get go. The FDA's response was essentially to blame the patient, since they do have mental illness after all, and claim that they had "faith" the drug was working as it should.

We should be scared to death
about the FDA ignoring
complaints about a generic drug -
but not about anything else?
Photo: Egahen/freeimages.com

Instead of conducting their own studies, the FDA then asked the manufacturer to look into the claims that the generic drug was not truly equivalent to the name brand. Even after they were forced to look into it themselves, they were slow to admit there was, in fact, a difference. Not only that, but they had to admit they only studied the 150 mg dosage, and didn't study the efficacy of the increased dosage at all, only assuming that it would work the same way. What was equally shocking: they received countless complaints and knew there were problems, but did absolutely nothing about it until they were forced to and could not contain the "problem" any longer.

This is, however, not the only case of bioequivalents not really being equivalent. The same is true of Synthroid and levothyroxine, used to treat thyroid disease, and some patients complain of a return of symptoms when being put on the generic drug. Most are told "it's all in your head" and insurance companies refuse to pay for the name brand preferred, even when it's clear the generic doesn't work for that particular patient. (If you want, you can read more here, but it's complicated.)

In this case, thousands of patients can be under treated for thyroid disease - which can lead to a host of other autoimmune diseases if not treated properly - not only keeping them feeling miserable, but eventually driving up healthcare costs in the long term. In the case of generic Wellbutrin, the author of the Forbes article rightly points out the toll is probably great: the number of people who, despite having mental illness, are perfectly capable of advocating for themselves and understanding their medicine isn't working; the number of patients who aren't able to advocate for themselves who are just further medicated into oblivion; and the patients who may have likely committed suicide because they were being inadequately treated. No doubt when that comes to light, there will be lawsuits, as there should be: and there are billions of dollars paid out to injured parties because of medication problems and recalls.

But why not vaccines? While there is the Vaccine Injury Compensation program, it seems like much is done to discredit and remove any possible link between vaccines and injury of any kind, autism or not. I personally don't know that I'd call it autism, per se, but in some children, no matter how "rare!" it is, there are still adverse reactions, some quite profound. You cannot expect parents to inject their children with a drug - and yes, it is a drug, with the possibility of creating side effects like any other drug - and poo poo their questions or concerns over it just because it doesn't happen to the majority of children. When you look at kids who are exhibiting marked, profoundly different behaviors shortly after vaccination that they never did before, you cannot simply dismiss them and encourage parents to remove their tinfoil hats of disbelief and forge full speed ahead into the most aggressive vaccine schedule this country has had to date.

Nor can you dismiss them from questioning the motives of "Big Pharma" and the FDA when it comes to vaccine efficacy and safety - because after all, this is the same entity that declared generic Wellbutrin 300 mg (and a laundry list of other drugs over the years) perfectly effective and "safe."

More reading:
Patients vindicated! Generic Wellbutrin withdrawn - The People's Pharmacy

'Tis the (flu) season

Ahh, fall.... cooler temperatures, changing leaves, and ... sneezing?

Judging from the bombardment of ads I see everywhere, it must be flu season. I wouldn't know, since the last time I think I had the flu, I was about nine years old.

Given my propensity to question authoritative figures (especially if they don't give me much of a good reason to listen), I've been on heightened alert for things like ads, billboards, and even register tape reminders about getting my flu vaccine. And I'm also paying attention to things like high drama, scare tactics and all-out pandering to the lowest common denominator to coerce, convince and cajole us into getting the shot.

These two billboards are sitting in a corn field down the road from my house. I sped by them one day, almost scaring my family as I nearly hit the brakes in disbelief.

Marketing technique #1: Using big, scary-looking font. That really gets their attention. (As a graphic designer, I'm all about the fonts.)

Technique #2: Make ambigious statements that make the average passer-by say, "Well, they say it's safe, so it must be." Never mind that there are no sources or mention of risks at all (there isn't that much room, anyway).

Technique #3, perhaps the best one of all: Use the cute, smiling kid to tout your product. Nothing says "I got vaccinated and I'm just fine!" more than the grin of a pigtailed child.

This one is bold, yet sly, at the same time. The urgency (in that big, bold font) is almost implying that health officials are lying in wait for you to pass, stopping your vehicle and asking for documentation that you have been vaccinated. Notice, though, the interesting use of a cell phone and truncated (if not totally annoying) "internet speak" that often appeals to the younger generation (those whippersnappers!) - who seemingly are more healthy than those who are most at risk for the flu, like the elderly and those with compromised immune systems.

Saying "Stop the flu before it stops you" is implying that something bad - really bad - might happen if you don't get the shot. You might be miserably ill, perhaps even miss school or work - for at least a week, maybe not even. That sounds bad. Like it might stop me. From going to work. Yeah, okay.

Target, I noticed, is offering some kind of flu shot program and is touting it left and right - I saw banner ads on their website as well as on my register receipt after making a purchase. Their marketing technique is a little more subtle, sort of giving you a gentle nudge - rather than screaming in your face like the county government does. How ironic.

"Your timing is perfect - we have flu shots! So give it a shot - come on, you know you're skeptical and riddled with fear but too afraid not to get one, so just go ahead! Dooooo it!"

This one offers you a $5 gift card if you get the shot.
Bribery works wonders. 

Now, again, if you're already ill and have a compromised immune system - like the elderly, for example - I can agree that the flu might present more serious complications for you and it's probably worth getting protected. Some say the flu vaccine can cut the risk of serious complications and death in older people up to half.

However, there is some speculation that perhaps the vaccine doesn't work as well in older people as once thought. Although it's anecdotal, I know my grandfather got the flu vaccine every year and, if I remember correctly, still got the flu. This is possible, as the vaccine admittedly does not work for everyone - it's estimated to be ineffective for about 30 percent of the population, apparently. Perhaps for my grandfather, he was one of that 30 percent. And after his last flu vaccine, my mom said, he just wasn't the same - and it was all downhill from there. He eventually died a few months later.

Could it have been from complications of the vaccine? Who knows. We probably will never know, and it seems like if it doesn't reach out and smack you over the head literally minutes from getting the vaccine, most health officials are completely unwilling to correlate the two. Perhaps because that would scare more people away from getting the shot, ya think?

This article from the Washington Post acknowledges that the government, especially, has often used fear as a heavy-handed scare tactic to "encourage" you to get vaccinated. There is probably a lot of wheeling and dealing going on behind the scenes - perhaps from the pharmaceuticals industry - to ensure that you keep buying what they're selling. If more people realized they were being used as tools perhaps they would second-guess waiting in line for two hours on a rainy afternoon to get that much-coveted flu shot.

I remember seeing a huge line of people at the mall one year, complete with security guards standing by - and wondered, "Are they buying concert tickets or something?" Then I looked at the crowd - which mostly consisted of older people in wheelchairs, and realized, They're waiting for the flu vaccine. As far as the elderly are concerned, there is some data to suggest that actually, many of them are already immune to several strains of flu - including H1N1 - because of living through past epidemics. Which means you waited in line for nothing, basically.

"Lab tests showed that some adults, particularly those older than 60, had antibodies against the new strain, but Dr. Anne Schuchat of the CDC cautioned against reading too much into the finding. 

"We don't know yet what that will mean in terms of actual immunity or clinical protection," she said on a conference call with reporters.

Which means, don't get too excited - just keep getting that flu shot. If we had a crystal ball (or lots of money to do additional tests) perhaps we'd find that more people wouldn't get H1N1 in the first place. Unfortunately the cost of blood draws might equal the cost of the flu shot. 

Common myths about the flu pervade, according to this article. Health officials say "It's impossible to get the flu once you've been vaccinated," (because the shot doesn't contain the live virus), but actually it is - because either you're part of the percentage in whom it was ineffective or because the particular strain you got is not even included in the vaccine. So you got the shot and go the flu.

The article also says that side effects of the flu shot are a "myth." I don't really consider listing soreness at the injection site and a case of the sniffles to be adequate counsel on the true side effects, which are no doubt uncommon but still exist. Several sites say that Novartis, the makers of Fluvirin, admit in their package insert that possible side effects can include paralysis and Guillain Barre Syndrome, which can cause paralysis and even death. However, the one package insert that I found lists it as a possible side effect, but only in connection to the 1976 swine flu outbreak, in which an elevated number of cases were reported after people received the vaccine. In other words, it sounds like they use that case as a scapegoat and want to distance themselves as much as possible from the possibility, perhaps in hopes that you'll say, "Oh, that happened 35 years ago - I don't need to worry about that."

The article, titled "Flu: You're not immune," ponders whether getting the flu can improve your immunity. 

“The natural immunity you build is usually more durable than the immunity you acquire from an injection,” acknowledges Dr. Raymond Strikas, associate director for an immunization program at the Centers for Disease Control and Prevention. “However, why run the, albeit small, risk of a serious illness when it is much safer to get the vaccination?”

The language many flu vaccine advocates use sounds serious, their tone warning - as if you are completely incapable of making the decision on your own free will. "Getting the flu is not a good idea," says one American Medical Association specialist. Of course you'd say that; you work for the American Medical Association. "The primary reason is that the influenza virus undergoes antigenic variation, so on a yearly basis the strain undergoes change." That's a fancy way of saying, according to the article, "Getting this year's flu doesn't necessarily prevent you from getting next year's flu."

(It also means getting this year's vaccine doesn't protect you from this year's flu, either, if you get infected with a strain that isn't included in the shot. You kind of glossed over that part.)

Reading between the lines here, I'd say even the CDC guy reluctantly admits the risks of "serious illness" are rare. Glossing over the reality of it, he basically eases into the guilt trip and encourages you to get the shot, even though it might not make a difference either way. 

The Cochrane Review did their own study, which basically found:

Influenza vaccines have a modest effect in reducing influenza symptoms and working days lost. There is no evidence that they affect complications, such as pneumonia, or transmission.

Rather surprisingly, they also acknowledged that nearly half of the trials were "funded by vaccine companies" and "company-sponsored influenza vaccine trials tend to produce results favorable to their products..."

The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies.

Something to think about before you get your next flu shot.