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Monday, March 02, 2015

Vaccines are "safe" and "effective"

Because they are totally "tested". By scientists doing science:

Merck, the pharmaceutical giant, is facing a slew of controversies over its Measles-Mumps-Rubella (MMR) vaccine following numerous allegations of wrongdoing from different parties in the medical field, including two former Merck scientists-turned-whistleblowers. A third whistleblower, this one a scientist at the Centers for Disease Control, also promises to bring Merck grief following his confession of misconduct involving the same MMR vaccine.

The controversies will find Merck defending itself and its vaccine in at least two federal court cases after a U.S. District judge earlier this month threw out Merck's attempts at dismissal. Merck now faces federal charges of fraud from the whistleblowers, a vaccine competitor and doctors in New Jersey and New York. Merck could also need to defend itself in Congress: The staff of representative Bill Posey (R-Fla) -- a longstanding critic of the CDC interested in an alleged link between vaccines and autism -- is now reviewing some 1,000 documents that the CDC whistleblower turned over to them.

The first court case, United States v. Merck & Co., stems from claims by two former Merck scientists that Merck "fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act]."

According to the whistleblowers' court documents, Merck's misconduct was far-ranging: It "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."

These fraudulent activities, say the whistleblowers, were designed to produce test results that would meet the FDA's requirement that the mumps vaccine was 95 per cent effective. To the whistleblowers' delight, the judge dismissed Merck's objections to the case proceeding, finding the whistleblowers had plausible grounds on all of the claims lodged against Merck.
Vaccine advocates, are you starting to find even a glimmering of understanding why some intelligent and well-informed people just might harbor the occasional doubt about the safety and efficacity of vaccines? If not yet, what more will it take? And do you not understand that once this level of fraud is established, it casts at least a modicum of doubt on EVERY SINGLE CLAIM that has been made about vaccine safety in the past?

Perhaps you'll even be able to understand why doctors have been hesitant to come forward with their doubts about vaccines if you consider the sort of response they can be expected to encounter from the vaccine manufacturers, who are legally protected against being held liable for the deficiencies of their products:
Merck made a "hit list" of doctors who criticized Vioxx, according to testimony in a Vioxx class action case in Australia. The list, emailed between Merck employees, contained doctors' names with the labels "neutralise," "neutralised" or "discredit" next to them. 
Do you find that confidence-inspiring?

Labels:

56 Comments:

Blogger Noah B March 02, 2015 12:06 PM  

Same thing is going on with antidepressants.

Blogger S1AL March 02, 2015 12:09 PM  

"And do you not understand that once this level of fraud is established, it casts at least a modicum of doubt on EVERY SINGLE CLAIM that has been made about vaccine safety in the past?"

Yeah, I was worried this would happen when the "100% safe" line started getting thrown around. Ah well. Biology needed its pilt-down man.

Blogger hank.jim March 02, 2015 12:11 PM  

This is different than the main reason parents don't vaccinate for causing autism. I would like to know what diminished efficacy means in the real world. Maybe not as effective. What about safety?

Anonymous Michael Maier March 02, 2015 12:14 PM  

"Noah B March 02, 2015 12:06 PM Same thing is going on with antidepressants."

God, please end that idiocy... The pill pushers are f'ing clueless on chemically-manipulating human brain activity.

They sure do sell a lot to women post-wall though...

Anonymous jack March 02, 2015 12:14 PM  

I don't understand. If vaccine makers are not legally liable for their products and claims how is this case proceeding? Don't get me wrong here. I hate the medical establishment in this country and DO NOT take vaccines.
Just wondering here....

Anonymous Tallen March 02, 2015 12:15 PM  

What about safety?

Exactly. What about safety? We're not allowed to know and not supposed to ask. Why would that be?

Blogger haus frau March 02, 2015 12:16 PM  

GlaxoSmithKline just got fined about $445 million by China for bribing public officials. The you dig into pharma graff the clearer it is they are just modern snake oil salesmen. By the way, there will be a rally against Oregon's forced vaccination bill sb 442-3 on the sidewalk outside the west steps of the capital building march 9th. We are trying to kill now t in the healthcare committee. That is the day of the hearing on that bill I believe.

Blogger Josh March 02, 2015 12:17 PM  

I would like to know what diminished efficacy means in the real world.

It means that the threshold for herd immunity might be impossible to reach.

Anonymous JN March 02, 2015 12:18 PM  

Same thing is going on with antidepressants.

I just noticed recently that they changed the age range where "suicidal thoughts" can be caused by anti-depressant. (The age went up.) My theory is that they will continue to increase the age until it covers everyone. The reasoning for slowly lifting the age is to avoid lawsuits from the relatives of those that killed themselves while on anti-depressants when they still claimed they didn't cause "suicidal thoughts".

Blogger S1AL March 02, 2015 12:18 PM  

@jack

Legal liability is tied to compliance with mandated testing methods. That's why the complaints against them are based on their failure to follow guidelines.

Blogger haus frau March 02, 2015 12:20 PM  

Jack, the federal government is the aggrieved party that's why its going forward.

Blogger Noah B March 02, 2015 12:22 PM  

"Jack, the federal government is the aggrieved party that's why its going forward. "

You've got to appreciate the irony. In China, drug companies fined for bribing government officials. Here, they get dragged to court when the bribes aren't big enough.

Blogger Northern Hamlet March 02, 2015 12:24 PM  

Isn't this merely the free market in action? In fact, do away with the regulations entirely and the FDA, problem solved.

In all seriousness though: I've always been leary about childhood vaccinations, and this sort of stuff is the final nail.

Blogger Bluntobj Winz March 02, 2015 12:35 PM  

The Rubella component's time will come, and it will be revealed that autism spectrum disorders have a prime causal link to human protein based prions from the growth medium for this vaccine, which is human diploid cells from an aborted fetus.

And quit threadjacking with the anti-depressant stuff. It's depressing...

Blogger haus frau March 02, 2015 12:36 PM  

China also executed ringleaders of the melamine infant formula scandal. Meanwhile no individuals have been held criminally or civily responsible forthe vioxx sscandal that killed thousands. By the way most of our vaccines are manufactured in China. I won't even by dog treats made in China. But that's A ok with the fda.

Blogger LP 999/Eliza March 02, 2015 12:46 PM  

Just like AGW this too will end as a bad farce for its deceived supporters. Still rather pathetic provaxers are this stupid.

Anonymous Titus Didius Tacitus March 02, 2015 12:57 PM  

Merck made a "hit list" of doctors who criticized Vioxx, according to testimony in a Vioxx class action case in Australia. The list, emailed between Merck employees, contained doctors' names with the labels "neutralise," "neutralised" or "discredit" next to them.

But that's a conspiracy theory!

:D

Blogger kurt9 March 02, 2015 1:06 PM  

In a normal court of law, if a witness is caught lying just once, it is considered reasonable for the jury to assume that any and all statements made by that particular witness are lies. This same standard of evidence should be applied in any kind of medical issue.

Blogger Salt March 02, 2015 1:13 PM  

Trusting a drug company over its drugs is like trusting your pusher. "You're sure this is safe?"

Blogger Karl March 02, 2015 1:15 PM  

1) This is false claims act case so it was started by the whistleblowers, however the feds have the option to take over the case.

"Qui tam lawsuits are a type of civil lawsuit whistleblowers bring under the False Claims Act, a law that rewards whistleblowers if their qui tam cases recover funds for the government. Qui tam cases are a powerful way for whistleblowers to help the government stop many kinds of fraud." link

2) The next time someone references scientific consensus, open up the Edmunds Scientific catalog and ask them what instrument scientists use to detect consensus.

Blogger YIH March 02, 2015 1:17 PM  

hank.jim:
I would like to know what diminished efficacy means in the real world.
Say you got this year's recommended flu shot and it doesn't do squat.
You took (and accepted) a risk (however small) that the shot can negatively endanger your health for no benefit whatsoever.
You literally played biochemical 'russian roulette'.

Blogger Danby March 02, 2015 1:22 PM  

@hank.jim
Read the rest of the f'ing article
" The third whistleblower -- a senior CDC scientist named William Thompson -- only indirectly blew the whistle on Merck. He more blew it on himself and colleagues at the CDC who participated in a 2004 study involving the MMR vaccine. Here, the allegations involve a cover-up of data pointing to high rates of autism in African-American boys after they were vaccinated with MMR. "

That's the connection.
Honesty and integrity may not be quanta, but once you corrupt the science, even by jacking the efficacy from i.e. 92% to 96%, there's no good reason not to go whole hog, and sacrifice kids. After all, even with a higher rate of Autism in some populations, MOST kids are protected, and society as a whole benefits.
Right?

Blogger Mark March 02, 2015 1:29 PM  

It seems to me this is the same problem with any industry, except distorted by government, isn't it?

That is, my understanding is that indemnification is because the profit margin is so small (because government imposed a price cap on the product). So government makes the job unprofitable, then protects the company from liability--is there any surprise there's cost cutting?

Restore the free market, and we'd get better quality and safer product. But I don't see how that uniquely applies to vaccines.

Blogger Nate March 02, 2015 1:32 PM  

"I don't understand. If vaccine makers are not legally liable for their products and claims how is this case proceeding? "

Its not a vaccine injury case so its not going before Vaccine Court. Its a fraud case. Very different

Blogger Danby March 02, 2015 1:40 PM  

@Mark,
Indemnification is usually used for activities that are considered vital, with small, unavoidable but catastrophic risks that could lead to the destruction of the actor.
A great example is the indemnification against terrorist activities that airlines have enjoyed since 2001. Airlines are indeed vital to the modern economy, but the risk of a terrorist taking out a plane, or multiple planes is real, though small. By exempting the airlines from that liability, a considerable amount of uncertainty is removed from the market.
Of course, with the airlines, the government stepped into the gap, and established a monetary pool with which to pay out claims on a stated schedule. With vaccines, you simply have no ability to recover damages at all.

Anonymous Dr. J March 02, 2015 1:49 PM  

Seroconversion rates for Merck's mumps vaccine may be lower than 65%, so of course the pro-vaxxers will blather on about how a 65% chance of success when there's "no risk" is still worth it.

It's unbelievable how parents will lie to themselves, their kids, and everyone around them to justify doing what everyone else is doing. Whether it's 15,000 vaccines before 4 months of age, dumping their kids off in daycare/public school, exposing them to vibrancy/diversity/gays.

Merck made a "hit list" of doctors who criticized Vioxx, according to testimony in a Vioxx class action case in Australia. The list, emailed between Merck employees, contained doctors' names with the labels "neutralise," "neutralised" or "discredit" next to them.

Oh shit - it's Franks!

Blogger Nate March 02, 2015 1:51 PM  

" With vaccines, you simply have no ability to recover damages at all."

Not true. There is a vaccine court and its awarded over 1 billion dollars since it was formed in the mid 80s. The difference is... the money awarded doesn't come from the vaccine manufacturers... its tax dollars.

Blogger Outlaw X March 02, 2015 1:55 PM  

I am getting damn tired of warning people two to 5 years before it hits the lying ass MSM and being called a kook for warning them early on. And how quickly they forget I warned them.

Human nature makes it easy for the liars and deceivers by telling people what they want to hear. It's why diet pills and bow flex sell so well. And also affordable government health care. DUMB-ASSES!

Blogger Noah B March 02, 2015 1:57 PM  

"In a normal court of law, if a witness is caught lying just once, it is considered reasonable for the jury to assume that any and all statements made by that particular witness are lies. This same standard of evidence should be applied in any kind of medical issue."

That standard should be applied to politics too.

Anonymous Mr. Rational March 02, 2015 1:59 PM  

Meanwhile, a prominent climate denialist turns out to have been financed by the fossil fuels industry:

http://truth-out.org/news/item/29331-climate-deniers-exposed-top-scientist-got-funding-from-exxonmobil-koch-brothers-big-coal

And to the surprise of no one who actually follows the science, the increase in downwelling IR due to increasing CO2 in the atmosphere has been directly measured and tracked over 10 years:

http://www.nature.com/nature/journal/vaop/ncurrent/full/nature14240.html

Blogger Outlaw X March 02, 2015 2:00 PM  

the money awarded doesn't come from the vaccine manufacturers... its tax dollars.

And it is almost impossible to prove vaccines did it.

Anonymous Aeoli Pera March 02, 2015 2:01 PM  

Outlaw X,

Chalk me up as one person who has listened to you at least once. May have saved my life, who knows?

Thank you very much, and God bless. :-)

Blogger Danby March 02, 2015 2:04 PM  

@Nate,
I didn't know that. Thanks for the correction.

Anonymous Aeoli Pera March 02, 2015 2:11 PM  

I wrote that before I wandered over to your blog and learned the bad news. God bless and Godspeed too :-/.

Blogger Outlaw X March 02, 2015 2:46 PM  

I wrote that before I wandered over to your blog and learned the bad news.

Appreciate it, but know I'm cool with it. I don't think we will ever straighten out this fallen world. Mans attempts are futile, it says so. Revelation 13: 7And it was given unto him to make war with the saints, and to overcome them: and power was given him over all kindreds, and tongues, and nations.

Anonymous Will Best March 02, 2015 2:59 PM  

Not true. There is a vaccine court and its awarded over 1 billion dollars since it was formed in the mid 80s. The difference is... the money awarded doesn't come from the vaccine manufacturers... its tax dollars.

Well it is funded by a tax on vaccines. The alternative would be vaccines would cost more money but then the company would be earmarking the increased amount for litigation and settlement costs. The true "benefit" of the public system is the stream lined discovery process whereby if bad stuff happens within 14 days and it can't be attributed to another cause you get paid. But after 14 days tough shit.

---

On a personal note my kids peds office had a standard MMR at 15 months. I have no idea their rationale for that over the CDC recommended 12 months, but they were browbeat into lowering it to 12 months with the latest push for mandatory vaccinations in the wake of the Disney thing.

They still are just recommendations, so you can still use a delayed schedule and they won't have a problem with it. I just find it telling that even a 3 month delay wasn't being tolerated by their peers.

Blogger Nate March 02, 2015 3:03 PM  

"The true "benefit" of the public system is the stream lined discovery process whereby if bad stuff happens within 14 days and it can't be attributed to another cause you get paid. But after 14 days tough shit."

Fascinating. Now explain how any other drug has such low bar for safety.

Anonymous TLM March 02, 2015 3:05 PM  

I really respected a small men's group teacher I was involved with years ago. He was an excellent Bible teacher, always possessing the ability to see clearly and keep Scripture in the context it was meant for. But he was, and presumably still is, a long-tenured Merck employee. I lost all respect for his leadership capabilities when he was willing to defend Merck's gestapo legislative tactics with the roll-out of Gardasil across the country. His blind zeal and defense of Merck in that time was incredibly off- putting for a guy I once had a high level of admiration & respect for.

Anonymous Will Best March 02, 2015 3:08 PM  

In a normal court of law, if a witness is caught lying just once, it is considered reasonable for the jury to assume that any and all statements made by that particular witness are lies. This same standard of evidence should be applied in any kind of medical issue.

The Jury is the decider of fact and are free to give as much or as little weight to any evidence they examine. A witness doesn't even need to be caught in a lie. If the Jury even perceives what he is saying is untruthful or even if they get the sense he is unlikable they start discounting what he is saying.

Anonymous Will Best March 02, 2015 3:11 PM  

Fascinating. Now explain how any other drug has such low bar for safety.

Why do you think I put benefit in quotes?



Anonymous Stilicho March 02, 2015 4:20 PM  

@jack, the lawsuit is a qui tam or whistle-blower action where the govt pursues the lawsuit and the whistle-blowers get ten percent of any recovery. The legal basis for the lawsuit is the allegations that Merck defrauded the govt.

Anonymous DT March 02, 2015 5:31 PM  

kurt9 March 02, 2015 1:06 PM - In a normal court of law, if a witness is caught lying just once, it is considered reasonable for the jury to assume that any and all statements made by that particular witness are lies. This same standard of evidence should be applied in any kind of medical issue.

A drug manufacturer caught systematically lying about their testing or manufacturing process should have their assets seized and sold to a competitor, with all proceeds going to injured parties. And that's on top of prison time for officers and employees proven to have been directly involved in the fraud. Let's see how many of them pull this shit when those are the stakes.

I don't care what field it is or what credentials the 'experts' have, human beings will lie to gain an advantage. Free markets, completely open testing and data requirements, independent replication of results (not peer review for a journal), strict and harsh penalties for fraud...that's how you deal with this nonsense.

Anonymous Allopathic Parasites March 02, 2015 8:27 PM  

Dissolving Illusions "Disease, Vaccines, and the Forgotten History"
Bystrianyk and Humphries

Blogger Admiral James March 02, 2015 8:49 PM  

This is not surprising. Let us not forget Merck's HPV vaccine which also had controversy in Texas when Rick Perry signed an executive order making the vaccine MANDATORY for girls entering the 7th grade which gave Merck a forced consumer to go with it's monopoly. It was discovered that the Governor had received campaign contributions from Merck and Mr. Perry had an in-law that was on the board for Merk.
Furthermore, the group with the forced compliance was the smallest study group of about 3000- which in research is nothing.
It was fast tracked with FDA approval after only one year just like Viox.
I guess HPV really stands for Help Pay for Viox

Blogger luagha March 02, 2015 10:07 PM  

"Restore the free market, and we'd get better quality and safer product. But I don't see how that uniquely applies to vaccines."

Well, not uniquely, but. Remember that it was Hillary's law that made the US Government the prime single purchaser of vaccines 'for the children.' They then reduced the price and from 25 manufacturers, 20 left the market as they were unable to make any return. (You'll remember that this was the time we had flu shot shortages in the US.) The remaining manufacturers reformulated their processes to make it cheaper, and as I now learn, moved their factories to China. And kids start getting autism. Hmm.

Blogger amm23116 March 02, 2015 10:29 PM  

What is the link to the article about the hit list for critics of Vioxx?

Anonymous The Shyster March 02, 2015 10:55 PM  

The False Claims Act is not used aggressively. It could be. Consider your local social services agency that is required to spend federal money for educational purposes, but is spending it for midnight basketball and pool parties. Or the abortion clinic that is required to do "outreach" and "education" with federal funds, but is spending them on abortions. Social services agencies are rarely, if ever, audited. In New York City, getting a government grant is a license to steal. Insiders say the agencies can go decades without anyone looking at their books. And (in many cases) their records are so bad that it can be very difficult sorting them out. The False Claims Act has rarely (if ever) used to go after these lefty fraudsters. But it can be.

Once you have established sufficient facts to support your pleadings (usually with the help of an insider), you can delve into all the agency records looking for theft and mis-spending. My guess is that better than half of the federal and state funds spent on urban charter schools are filched by someone in violation of the law. But there is a natural reluctance by local politicians to demand any accountability.

With the False Claims Act these agencies and interest groups can be held to account by citizens with legitimate concerns about the expenditures ... and you might get a bit of cash, too.

Anonymous The other skeptic March 03, 2015 12:50 AM  

Dissolving Illusions "Disease, Vaccines, and the Forgotten History"
Bystrianyk and Humphries


Or Dissolving Illusions: Disease, Vaccines, and The Forgotten History

It is 2,058 in books. Seems very popular.

Blogger Danby March 03, 2015 12:58 AM  

@amm23116
from The Australian in 2009:
http://www.theaustralian.com.au/news/drug-company-drew-up-doctor-hit-list/story-e6frg6n6-1225693586492

Anonymous Peter Pan March 03, 2015 1:14 AM  

I'm not sure I understand the exact procedure for this. Four of six counts were dismissed in the case, and one count was partially dismissed. I'm assuming this means the count and partial count surviving the dismissal are still pursued by the plaintiffs. If this is so, does this mean the case is still open?

Also, for anyone who cares enough to look at it, here is the memorandum for the case.

http://business.cch.com/ald/USMerck952014.pdf

U.S. ex rel. Krahling v. Merck & Co., No. CIV.A. 10-4374, 2014 WL 4407969, at *4 (E.D. Pa. Sept. 5, 2014)

Anonymous Fascism Works March 03, 2015 10:29 AM  

20 left the market as they were unable to make any return

That is what Gov does for the biggest Corporations who can (purposefully) weather the financial storm - it grants monopolies. That is one of the very purposes of legislation - to be rid of smaller, hometown, intimate mom and pop pharmacies, who may do things "other" than what CVS, Walgreens, WalMart and all the rest have agreed to do.

Licensing and Regulation is not "for your own good". It is a business model of musical chairs coming and going, and is nothing if not blackmail, set to the tune of giant profits.

Gov did not distribute those flu vaccines to Billy and Martha's small town RX.
Walgreens was subsidized by taxpayers, who then turned around, believing the absurd environment of propaganda brownshirts, and paid yet again for the flu shots.

Walgreens employees rewarded with iPads for meeting flu shot quotas


Anonymous Statists are so dull March 03, 2015 11:20 AM  

Increased hygiene correlates exactly with reduced diseases (type and incidence). Vaccines are like the suburban tiger deterrent in that old joke: it must work because you've never seen a tiger in the neighborhood.

Correct hygiene includes limiting sexual partners in number and restricting it to the biologically appropriate orifices.

Eating/ playing with poop > disease - it's not exactly witchcraft is it?

Anonymous takin' a look March 03, 2015 1:23 PM  

-Noah B

SSRIs especially. They fry out your emotional neurons and give you delightful "Brain Zaps" when you attempt cold turkey.

Blogger Outlaw X March 03, 2015 2:17 PM  

SSRIs especially. They fry out your emotional neurons and give you delightful "Brain Zaps" when you attempt cold turkey.

I was on effexor for 5 years, maximum dose until 2009. I lost most my friends and was having problems at work toward the end. I talked to the doctor about quiting a he said no, you need to stay on it and when I told him I wws going to lose my job he changed it and gave me a presiption of zoloft which I threw away and quit cold turkey. It had to be the worst two weeks of my life which I hallucinated, and drank a pint and one half of100 proof vodka to stop my brain from firing. Luckily I got my hands on some benzoprine and got though it.

Anonymous robwbright March 03, 2015 3:15 PM  

As an attorney, I used my access to the federal docket to download a copy of the Plaintiffs' Response to Merck's Motion to Dismiss. It can be found at the link below. Reading it, you can see why the Judge did not grant the motion to dismiss.

https://www.scribd.com/doc/254518357/Response-to-Motion-to-Dismiss

Anonymous robwbright March 03, 2015 3:28 PM  

Here you can review 222 cases where the vaccine injury court granted compensation to the family - and you can read the final order:

http://www.mctlawyers.com/vaccine-injury/cases/

Don't be thrown off by statements in the orders like: "Respondent denies that the immunization caused petitioner’s injury or condition."

That's standard language in just about any settlement. You'd see a similar denial of responsibility by the Defendant in a car accident case settlement.

The government has good reason to settle the cases while denying responsibility. After all, if the case actually went to full hearing and a finding of vaccine caused injury was made, then the media might cover that finding, the public might be informed and there might be a "panic". What do you think would be the result of hundreds of specific findings that kids were seriously injured by vaccines hitting the front pages?

Prosecutors don't prosecute cases with no evidence - even if there's a body - because they'd lose. Defendants don't go to trial in a case when there's clear evidence that the Defendant committed the crime or caused the accident.

Likewise, if a vaccine case is any good, they're going to settle the case with a statement that they deny causation.

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