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Monday, February 23, 2015

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

2 comments:

Anonymous said...

Thank you so much - great article!!

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