Unearthing Fraud In Medical Trials

An anonymous reader writes: The U.S. Food and Drug Administration holds a position of trust among citizens that few government agencies share. So when NYU professor Charles Seife found out the FDA is not forthcoming about misconduct in the scientific trials it oversees, he and his class set out to bring it to light. "For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers." Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.

Comments

let me annotate that for you

[Anonymous Coward]

"...the FDA is trapped in a co-dependent relationship with the pharmaceutical *and food* industry."

Re:let me annotate that for you

[Paradise Pete]

"...the FDA is trapped in a co-dependent relationship with the pharmaceutical *and food* industry."

That's for sure. The whole "Eat lots of grains and avoid fat" nonsense killed more people than did faulty pharmaceuticals.

Re:let me annotate that for you

[LifesABeach]

Maybe when your loved one lies dieing in your arms from eating taited food, or a toxic medicine; you will maintain your optomistic judgement? I'd watch it on Pay Per View.

Yawn

[g0bshiTe]

So sick of hearing "US knows of wrongdoing, we have proof" yet never ever is there any accountability.

Wake up people it's time to make Washington work and listen to us again!

Re:Yawn

[ihtoit]

there is no accountability because Government is nothing more than puppetry for industry.

You get what you pay for.

Re:Yawn

[rtb61]

Far more accurately you get the government that you allow the corporations to buy and you are the one that ends up stuck with the bill.

Re:Yawn

[penguinoid]

there is no accountability because Government is nothing more than puppetry for industry.

You get what you pay for.

When it comes to government, you get what other people pay for. You don't have the option to pay nothing/get nothing.

Re:Yawn

[jonow]

Yea, but that doesn't roll off the tongue quite as easily as "You get what you pay for."

Re:Yawn

[dryeo]

It's a free country, you have just as much right to spend hundreds of millions of dollars to buy your own laws. Of course being a free country means others have the right to outbid you.

Re: Yawn

[Anonymous Coward]

Nope, you get a lot more than you pay for. A dollar spent on campaign contributions, lobbying, and PACs,gives a 10 fold return in form of tax breaks, lax reggulation and other benefits.

Re: Yawn

[s.petry]

Only true if you can afford the down payment. You can't buy a mayor for less than 10 big ones today.

Re: Yawn

[ihtoit]

we have a general election coming in May. What's the betting I can get an audience in the Commons chamber before it breaks for the campaign if I write a cheque for say, seven digits as a direct contribution to a campaign fund?

As a counter-wager, what's the betting I won't get anything more than a boilerplate refusal if I simply ask my MP (Lillian Greenwood, Lab. Nottingham South) to get me that same audience out of her sense of duty to her public function?

Re:Yawn

[Anne Thwacks]

Hmm Methinks: Not so much a free country as an expensive one.

Re:Yawn

[LifesABeach]

I was thinking, "Money, the Mothers Milk of Politics."

Re:Yawn

[LifesABeach]

Wrong, America is a liberated country, everything here has a price.

Easy fix.

[bigfinger76]

The FDA probably just doesn't have enough women.

Congress is Codependant.

[Anonymous Coward]

The FDA is co-dependent? What are you smoking?

Medicare+Medicate is 2-3% of your total pay. Plus heaven forbid you ever have to use it for something serious, then they treat it like a loan and come in and start taking your property.

Health insurance (now Mandatory!) is $80-120\month\person that you see on your check; on the other side is the $400-600 a month you do not get to see.

Plus the exemptions to Antitrust laws that would make a Robber Barron blush.

"Oh but my family insurance is only $180 a month! For a family of 4!" Yep, so that gets cost shifted onto everyone else, and the company gives you a nice $15,000 a year policy while the single person down the hall is wondering if they should even try to have a family with pay-rates so low. Eventually, of course, they get to the point they realize they have nothing to lose, then you have real trouble.

Did I mention the insurance companies and the medical companies call each other on claims, and the medical company LITERALLY bills the insurance company so your "we pay 80% you pay 20%" liability becomes "you pay it all, the medical company and our insurance company makes a little on the side". Try getting a price upfront. "Oh every surgery is different", try saying that to the MASH units in Vietnam.

All in the name of what? Compassionate care for everyone. The result?

  Guess what congress is going to get forced into cutting in the next few years or else it goes bankrupt and we are done as a country? "Oh they can afford to" they can afford to by printing money, because more taxes means an economic crash and less tax revenue's, or the fed cranks up the printing press and dumps so much capital that a quarter of the public cannot afford to eat? Since 2008 we've gone from 800 billion in actual cash to over 3 Trillion; how much have food, property, supplies, and so forth gone up since 2008? Ground beef used to be $2.99 a pound, now it's $4.99. You haven't felt it as bad because the debts issued from that currency are standing at about 54 trillion, and the banksters are out of suckers and can't bring in mexicans to issue enough debt to in order to keep the "status quo" going.

So yeah, go fuck yourself and your "they just need a little legislative help". That's like saying "oh that person over there is bleeding to death, lets get them a little help, hand them a magazine". We're being fucked 9 ways from Sunday by banksters and medical oligopolies, you think we just need a little bit o' help. What rock are you living under?

What we need to do is have everyone cancel their insurance, tell the IRS they can go !%!@#ck themselves on their $3,000 fine.

I'd rather have the money now so i can live happy with what i have, and when my sand-glass runs out, bullets cost $.25. Instead, I get to go long on lead.

FDA == slow progress too

[javilon]

Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.

This is clearly the case, and this not only means that some drugs that should not be on the market are approved. It also means, and in my mind this is more important, that the big Pharma are using the FDA as a barrier of entry against startups. Getting a new drug on the market costs an average of $2.558 billion in 2013 dollars.

This days are the early days of the biotech revolution where we will gain enormous control over our health are just starting, and progress is slow due to regulation capture. If some of this money would be given back to researchers instead of lawyers and bureaucrats, we would get better treatments available sooner.

As an example, big pharma companies get old drugs whose patents are about to run out, change their chemical formula and improve them just a bit and then go to market with them so the can reap huge margins with basically the same compound. This is safer business than trying to produce a breakthrough with a completely new compound. And the reason for this is the way the FDA operates. This results in very valuable resources being used with little benefit to the public.

Re:FDA == slow progress too

[rock_climbing_guy]

A million times this. I recently heard some news about a new medical discovery. It is a treatment for a chronic illness called "cluster headache", which reportedly causes such severe pain that people literally kill themselves to stop the pain.

A CH sufferer serendipitously discovered that using LSD recreationally stopped his pain. Word quickly spread among CH sufferers, but as you can imagine, they were worried about being busted by the man who wears the badge.

A medical researcher got wind of this and did some rudimentary research on a drug that is chemically similar to LSD, but does not cause a "high"; in other words, it has no abuse potential. He made a remarkable discovery: many of the patients he studied reported that taking just THREE DOSES PER YEAR stopped the pain.

The problem then, is that the illness is rare enough that you could never make back $2.5 billion dollars selling three pills per year to patients, so no big pharma company would want to go thru all the red tape to get it approved by the FDA. As a result, there remains no effective FDA-approved treatment for CH.

Many of these patients continue to self-medicate with old-fashioned LSD while looking over their shoulder for "The Man". How sad....

Profit indeed comes before people, but I had no idea how abusive the system could be. And for the record, I do not have CH.

Re:FDA == slow progress too

[TapeCutter]

The "average" is supposedly $2.5B, that doesn't mean they all cost that much (or little), the money is mainly spent on clinical trials. Part of the problem is that many countries (including mine) rely heavily on the FDA, they take the fruit of the trials for free. The problem with LSD in particular is that it is on the wrong side of the drug war. Adults should be free to take whatever drugs they want and should not be forced to have vaccines.

However consumers should be held responsible for their decisions when it affects others, being drunk or stoned should not a mitigating factor when you wipe out a family with a car, it should be an aggravating factor as DUI is now. Same goes for people who sell the drugs, those who repeatedly make false or baseless claims about medicine for personal gain should, at the very least, be stripped of all assets and condemned to minimum wage for the rest of their lives.

Re:FDA == slow progress too

[fermion]

Also the washington post reports a John Oliver story that most pharma companies spend more on marketing than research. A number of stories has come out over the past few years indicated that phramcos essentially pay doctors to prescribe their drugs.

The real issue here is the idea that medical science is in fact a science. It may have elements of science, but if science is to flourish we must root for the null hypothesis, and there is no incentive in medical science to so do.

No, everyone want to believe the snake oil works. The desperate patient who wants to believe the snake oil will magically cure the illness. The doctor who is going to be paid a huge sum of money to promote the drugs. The legislators who need to win the next election. The regulators who want to get a job after they do their government stint.

I would support allowing risky drugs to be used for terminally ill patients, even children. What I don't support is the routine use of drugs we know are dangerous, and then the litigation after the fact, which arguably a major reason drugs are more expensive. Don't put dangerous drugs on the market, and the pharmcos would save billions, if not ten of billions.

Re:FDA == slow progress too

[Dorianny]

The problem then, is that the illness is rare enough that you could never make back $2.5 billion dollars selling three pills per year to patients, so no big pharma company would want to go thru all the red tape to get it approved by the FDA. As a result, there remains no effective FDA-approved treatment for CH.

Under U.S law rare diseases are designated as "orphan disease" and the FDA can give " orphan drug" status to drugs specifically targeting the rare disease. The law gives tax incentives, enhanced patent protection and even subsidizes clinical research. In the U.S there is more than 300 orphan designated drugs under clinical trial process. The problem with your LSD like chemical is that it is likely so similar that you are in dubious legal ground with regard to anti-drug legislation. That is not the fault of either the FDA or the pharmaceutical industry.

Re:FDA == slow progress too

[Chikungunya]

Sorry but this is just not believable, a large part of the cost of developing a drug is to put in place clinical trials in humans, the "rudimentary research" that this medical researcher did actually would be exactly this. First he had to finish a large number of toxicity tests on cells and animals just to give a single dose to a human, and if he treated patients then he already had to finish the safety test (done on completely healthy volunteers) on top of that he already got to test humans for at least a year? he would have already paid most of the cost of putting the drug into the market. Any kind of money they could get from it would be best than just losing everything because they did not want to expend in the final paperwork (not to mention any other possible uses for the same compound to be discovered later, the propaganda value for the company, etc.)

Either the story is just fabrication or the "researcher" is a completely unethical rogue who should be in Jail.

Re:FDA == slow progress too

[markass530]

https://www.indiegogo.com/proj...

Re:FDA == slow progress too

[lazy genes]

I recently was prescribed a medication that relieved my cluster headaches. Its called verapamil. It worked within a couple days and have been headache free for several months now. I can see why so many people kill themselves over this type of headache.

Re:FDA == slow progress too

[rock_climbing_guy]

Hi Lazy! I'm very glad to hear that you're feeling better, regardless of what treatment you're using. I'll be first to admit that I'm not a CH expert and I don't know all the facts, but I hate to know that there is a painful illness out there and be told that red tape is holding back progress in treating it. Here's to many pain-free days to come, for you!

Re:FDA == slow progress too

[Anonymous Coward]

Adults working in service (i.e. 90% of the population in modern post-industrial countries, and the ones producing 90% of the wealth) are ethically bound to take vaccines, and their employers must mandate them unless there is clear documentation of ineligibility.

Re:FDA == slow progress too

[Anonymous Coward]

... self-medicate with old-fashioned LSD ...

LSD was originally a psychotropic medicine. Then it became popular for recreational use and was banned.

Re:FDA == slow progress too

[Anonymous Coward]

This story is probably a bullshit. LSD is not a miracle drug.

Re:FDA == slow progress too

[Anonymous Coward]

The problem with your LSD like chemical is that it is likely so similar that you are in dubious legal ground with regard to anti-drug legislation. That is not the fault of either the FDA or the pharmaceutical industry.

Neither the FDA nor the industry wants Americans to have unregulated access to drugs. Nor do they want us to have regulated access to the same drugs Europeans or Canadians or Mexicans can buy. Nor do they want to compete with recreationals (vs anti-depressents, their brand of happy pills, etc.). They sure as fuck are responsible. It doesn't matter what 3-letters use, they're in the same boat. The FDA blaming the DEA is just one hand pointing to the other. When a murderer does that, we lock up the whole person.

FDA due for reform

[jd.schmidt]

The FDA should have it's scope limited somewhat, focusing more on purity of things is regulates and less on effectiveness and uses. I have heard of various cases of outside influence and political pressure in the past. I think a more open source/wiki approach to medication effectiveness might be better. There is always a big danger of misuse when so much is relying on one organization with no outside checks.

Re:FDA due for reform

[trout007]

I think it should serve two purposes. One like you mention is purely. Make sure what the manufacturer says is in there is correct.

The second is continue doing trials but only as an advisory function. If companies want to pay for the FDA seal of approval so be it. If not you can sell your drug with a warning it hasn't been tested.

I try to to take drugs that have been out for 20-30 years. If I was really sick I might get more desperate.

Re:FDA due for reform

[rock_climbing_guy]

You could start by putting a stop to the sting ops and SWAT raids on farmers who sell raw milk.

Re:FDA due for reform

[TapeCutter]

A SWAT raid seems a tad excessive but I assume you're posting from the US, so who knows? However, there's good public health reasons for banning the sale of raw milk, nobody is banning foolhardy and ignorant nature nuts drinking it straight from the cow, they are stopping people from profiting from the ignorance of others. Pasteurising milk is simply the act of boiling the milk to kill the nasties (such as tuberculosis), it used to be called "scalding the milk" before anyone figured out why it worked. Homogenised simply means the cream and milk have been mixed in such a way that the cream no longer rises to the top. The problem I have with supermarket milk here in Oz is that virtually every one of the countless different types have something added or removed, ie: it's not milk. It can actually take quite some time to find plain old full cream milk in a supermarket, if it's there at all.

Re:FDA due for reform

[Anonymous Coward]

If you actually read the Wikipedia page on pasteurization or had ever been to a dairy farm you'd be supporting the sting ops and SWAT raids on farmers selling raw milk.

Drinking non-pasteurized milk just puts you up for a Darwin award.

Re:FDA due for reform

[markass530]

no, not at all, that crap kills people .

Re:FDA due for reform

[rock_climbing_guy]

I understand that there are risks involved and the benefits are dubious, but I'm one of those odd-ball whackjobs who thinks that it isn't Uncle Sam's business what foods I choose to eat. Maybe in a few more generations, people like me will die out and we'll have a docile population of people who do what they are told without question.

Re:FDA due for reform

[Anonymous Coward]

It is a problem of information asymmetry. Banning the sale prohibits use of advertising budgets to advocate practices scientifically proven as unsafe. Otherwise....

Re:FDA due for reform

[Anonymous Coward]

"scientifically proven"
-NotAScientist

Re:FDA due for reform

[Rockoon]

The FDA should have it's scope limited somewhat, focusing more on purity of things is regulates and less on effectiveness and uses.

Prior to 1962 the FDA only required proof of safety before a drug could be sold and marketed. The mandate was changed in 1962 to include efficacy, and the excuse for doing so were the birth defects caused by thalidomide in Europe. Note that thalidomide was quite effective, but not safe, which is why the FDA already didn't allow it to be marketed or sold in the United States. The FDA pounded its own chest and asked congress for more control even though it didn't need it to prevent thalidomide birth defects in the States, and thus congress passed the Kefauver-Harris Drug Amendment.

Thats it right there. Before 1962 the FDA didn't care about efficacy. After 1962 it did, and all because the FDA's safety mandate was good enough.

Re:FDA due for reform

[Anonymous Coward]

A SWAT raid seems a tad excessive but I assume you're posting from the US, so who knows?

American SWAT cops simply LOVE this kind of op. There is absolutely no risk and they still get to storm about and look important for the TV cameras in their ski-masks, military armour, automatic weapons, grenades and jackboots while some PR guy spouts platitudes and propaganda to the reporters.

Government bait and switch

[sdinfoserv]

Most government agencies are mere puppets for the owned representatives in office. Like the FDA, the EPA will not protect the interest of the citizens but rather corporate interests. Many victims of fracking where once fertile land has become toxic have found the EPA's sole job is to protect the frrackers, not the land they supposedly steward. Commerce Department is another example. The Commerce Departments job is to protect and secure 'commerce' not individuals but huge corporations. The FBI diligently attacks people who illegally share music - with the same ferocity as mass murders or terrorists.

Net neutrality will become another victim. It will eventually die since It 'burdens' profiteers.

. Our rights as citizens is a veneer. Till we change how campaigns are financed, corporate puppets will continue to operate with impunity sealing more and more wealth from the masses for the benefit of the few.

Re:In b4 stupid libertarians

[Anonymous Coward]

Libertarians decry fraud, and view prevention/punishment of same as one of the legitimate functions of government.

I don't know who you've been talking to, but if they're calling what you describe as libertarian, they're lying. (Both Democrats and Republicans would rather nobody understood what Libertarians really stood for, or they'd see their voter bases begin to evaporate.)

Don't crucify the FDA. They came out long ago...

[bogaboga]

Didn't they agree to this long ago? What do you expect anyway?

From the piece, authored more than half a decade go, "The FDA now admits that Americans are suffering and dying because the FDA does not have the scientific ability to ascertain if new drugs are safe or effective or to evaluate scientific claims." (Bold mine).

What troubles me though, is that most Americans believe our country has the "best" medicine or healthcare one can find anywhere on planet earth.

You don't have to be a genius

[future assassin]

to realize something shifty is going on when drugs that mask/fix one problem cause 10 other ones or death at time or serious addictions. How can a drug that causes death in some instances be allowed on the market?

My wife was put on some anti anxiety drugs by her doctor. It made her feel like shit and gave her nasty shakes. She stopped taking it and went back to the doctor a couple weeks later. He gave her a big speal that she cant do that as it could have cause her to commit suicide WTF!!!!!!!!!!!!! and she has to come off it gradually. Then same thing happened to a friend of mine with the same drug. The doctor warned him he can't just cold turkey the drug and has to come off it gradually. They were both like if I the side effects are worse than the any symptom caused but the anxiety why the hell would be on this drug.

Re:You don't have to be a genius

[TapeCutter]

Lemme guess - Zoloft?

Re:You don't have to be a genius

[future assassin]

Can't remember the name but yah something with Z.

Re:You don't have to be a genius

[bigtrike]

This is true of all SSRIs. There are withdrawal symptoms and you're supposed to taper off to minimize them. Her doctor should have explained this to her, the pharmacist should have explained this to her, the prescription most likely came with literature explaining this, and there should have been a sticker on the bottle warning to her consult her doctor before stopping it. I had the same issues with Celexa, but tolerate Lexapro without issue. The side effects SSRIs are far better than the older tri-cyclic anti-depressants, but it not all of them work well for all people.

If you are competent in drug development ...

[BoRegardless]

Do you work for the FDA for a government civil servant wage reviewing other company's work or do you go to work for industry and earn the wage you trained for?

Same thing at the US Patent & Trademark office. Patent examiners come in, learn the ropes and go out to become patent attorneys in the private sector.

Same thing happens at the IRS.

Government doesn't keep the brightest bulbs because of pay and bureaucracy.

Re: If you are competent in drug development ...

[Anonymous Coward]

That has changed. US Government pays 30% more on average than private sector for the same job. Starting pay may not be par but because of strong unions, seniority is all that matters.

Trust?

[Anonymous Coward]

"The U.S. Food and Drug Administration holds a position of trust among citizens that few government agencies share."
Says who? Nobody "Trusts" the FDA... Especially after they have refused over and over to label GMOs while 112 countries worldwide have OUTLAWED their use OUTRIGHT! GMO corn and Soy are PROVEN to cause CANCER in lab mice... PROVEN FACT.... So, yeah... FU CK the FDA!

Re:Trust?

[rock_climbing_guy]

Yes, FCUK the FDA! One of the most thoroughly corrupt agencies in the fedgov. I can't believe we actually put up with their bullshit.

Re:Don't crucify the FDA. They came out long ago..

[Anonymous Coward]

Didn't they agree to this long ago? What do you expect anyway?

From the piece, authored more than half a decade go, "The FDA now admits that Americans are suffering and dying because the FDA does not have the scientific ability to ascertain if new drugs are safe or effective or to evaluate scientific claims." (Bold mine).

What troubles me though, is that most Americans believe our country has the "best" medicine or healthcare one can find anywhere on planet earth.

We do have the "best" medicine, mostly because the HIV tainted plasma and other contaminanted drugs are barred from sale here.
So that get shipped out of country to be sold in foreign markets.

WTF is with all this sensitive, new age jargon...

[spads]

...suggesting the "FDA is in a co-dependent relationship with the pharmaceutics industry and need strong legislative support to end this bad behavior"? Is there no such thing as accountability anymore? Are we all so hopelessly helpless we need some great (HIGHER-KNOWING/wise) ~~group~~ to come along and help us wipe our A$$ES? My guess is the TF Author simply ~~wants~~ to be ~~reamed out~~.

Let me see if I can get this straight...

[slew]

Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.

He wants the completely-non-influenced-by-big-money legislature to do something about the FDA being co-dependent with big-pharma...

Yeah, that sounds like it's gonna work...

Re:Don't crucify the FDA. They came out long ago..

[sjames]

Most other countries (but not all) have the same laws and reasonably effective enforcement. We *DO* have the most expensive medicine though.

Re:Don't crucify the FDA. They came out long ago..

[Anonymous Coward]

Interesting, thank you.

When the Federal Food, Drug, and Cosmetic Act was originally enacted in 1938, the regulatory and compliance issues FDA faced were comparatively simple. From that modest beginning, however, FDA’s role as gatekeeper to new products has expanded enormously13. Through the enactment of a series of landmark statutes, beginning in the 1950s and extending through the 1970s, FDA was given a mandate by Congress to review and approve prior to marketing, the safety of color additives, human food additives and animal feed additives, as well as to review and approve the safety and effectiveness of new human drugs, new animal drugs, human biological products and medical devices for human use. As a practical matter, today no new pharmaceutical product or medical technology can be used in the US without FDA first determining that it is safe and effective for its intended use. In 1990, Congress added pre-market approval for disease prevention and nutrient descriptor claims for food products, and in 1994 it added pre-market review for newly marketed dietary supplements.

The Subcommittee found that the FDA lacks sufficient expertise in quantitative methods, such as statistics and biomathematics, to effectively assess products and guide sponsors to design valid and informative studies.

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

By "quantitative methods" they appear to mean analyzing the data. According to that report the FDA cannot tell if a treatment is effective or not.

And people wonder...

[PermacultureEngineer]

If anyone, anywhere wonders where the anti-vax movement came from, here you go. I am NOT defending the antivaxxers. Vaccinate your kids, dammit, and yourself too! But is it any wonder that people have come to systematically distrust experts when the institutions of expertise have been shown repeatedly to be corrupt to their core?
I am agnostic as to whether we have more corruption than we used to, or just more public awareness of it. I suspect the latter case, but it doesn't really matter. Getting people to act like good citizens requires trust in public institutions. If that trust has been destroyed, good citizenship goes with it. We can't put the information genie back in the bottle, even if we wanted to, so we'd best figure out how to start building trustworthy public institutions.

This probably starts with NOT cutting their budgets to the bone.

(cue the libertarian clown car, to tell us that public institutions are not necessary, in 3... 2... 1...)

Re:And people wonder...

[Anonymous Coward]

FDA budget is already paid for the the companies they regulate and not the taxpayer. The culture in FDA is to talk about "the customer". The only people who can stand working there are those taking a tour through the revolving door to climb the corporate ladder.

Re:And people wonder...

[s.petry]

No, Yes, No, and No again.

No to the first part is based on who owns the argument and what they want your perception to be. Hint: It may not be the real argument.

Remember that 5 companies that own all broadcast media in the US, Government agencies like the FDA are revolving doors for agriculture and pharmaceutical company exec's, many News Papers have been complicit in cover ups (see NY Post whistle blowers, Washington Post, etc..). Finally consider that even small papers rely on Government agencies like the FDA for information (you did read TFA right?).

Are most anti-vaxxers really anti-every vaccination, or just against the ones that treat the small threats and come with high risk? Here is an exercise for you. What is the highest modern (post 1970) morbidity rate for influenza? What is the morbidity rate of the vaccine? Now do that same comparison with the highest morbidity rate for Vericella (Chicken Pox).

I know plenty of people that have had, and fully support most vaccines but not the two I mentioned. Believe it or not their decision is not "crazy anti-vax" stuff like the media portrays, it's based on the numbers. Run the numbers yourself, don't take anyone's word for it. Everything is available through the CDC and US Census data. You may not agree with their opinions, and that's fine.. but you will at least understand their opinion is not "crazy".

That's not saying there are not some whackos who are completely against all vaccines, it's saying that is not the prevalent issue with people.

The second part, I fully agree with. The Government and people in public positions must be trusted. Many of us lost trust decades ago. Funny that things I talked about then resulted in "tin foil hat" comments, and "crazy", and "conspiracy theorist" yet today it's all been proven to be true. I'm honestly glad that more people are catching on, maybe the momentum will finally swing and we can fix things without a revolution. I'm doubtful, but always have hope.

To the third part, this has nothing to do with budget cuts. We pay more in taxes today than any other time in history. Middle class people are paying 30-40% of their income in taxes, and Government tax revenue is simply staggering. It's wasted in layers and layers of cronyism, nepotism, bribes, and hush money but the money is in the system.

To the last part, again you have been misinformed (see the opening about media). Anarchy is not the same thing as Libertarianism. Libertarianism is about reducing Federal institutions, not abandoning them. Read just about everything Ron Paul put(s) out, and that aligns with the majority Libertarian view. As with anti-vaccine people there are surely exceptions, but that is not the prevalent view from Libertarians.

Re:And people wonder...

[LifesABeach]

One only need look at a picture of a Polio Ward to know the truth. As for those that do not 'vax their decendents? They can watch them die.

Re:And people wonder...

[murkwood7]

What numbers?

The ones available from the FDA? The CDC? Some other government agency?

Re:And people wonder...

[s.petry]

I think you are trying to hint that the CDC is not accurate. I'm pretty sure they are kind of accurate, but to get the real picture you have to dig pretty damn hard into their information. They don't make it easy.

Have a better site for numbers that can't be flagged as biased? I'll take a look.

Re:And people wonder...

[Anonymous Coward]

>If anyone, anywhere wonders where the anti-vax movement came from, here you go.

Considering how much anti-vaxing was being pushed by shill callers on propaganda-contractor talk radio, I think it might also have been an effort to inflate the perceived immigrant problem without it being obvious enough to generate resentment/backlash. That position was pushed on both local programming, and the national pseudo-science talk.

Those public service announcements about bigger tips when you eat out lose the veil of kindness when one realizes that the driving force is from businesses that would like to pay their employees less or even nothing.

The loss of the fairness doctrine and free media has seriously harmed democracy in the U.S. And it keeps getting worse.

Re:Don't crucify the FDA. They came out long ago..

[Duckman5]

Are you kidding me? Did you read where that came from? It's reposted from Mercola.com. The guy is a anti-vaxx quack with a minor history of battling with the fda. Not only that, but those extra regulations on supplements threaten his livelihood.

Does any of that mean that the FDA is perfect? No. The structure of the FDA is retarded. They require a whole series of clinical trials, have the evidence presented to their advisory team (composed of actual scientist and medical professionals) who make a recommendation, then a group of people (who have no legal requirement to know ANYTHING about medicine) vote on whether to approve the drug or not. That's how you end up with stupid garbage like Aricept 23mg getting regulatory approval (Over 2x the side effects with almost negligible gain on Mini Metal Status Exam compared to the 10mg dose? Yay! Put Grandpa on it today!)

The FDA is also only allowed to look at safety and efficacy data. They can't deny something on the basis of utility. Companies like this one make a killing on it. I'm not aware of a single novel medication that company makes. All they do is take stuff that has been on the market for decades, make it a gel instead of a cream or combine two products (so convenient), sell it for 10 or 20 times the generic price, and send an army of sales reps to convince gullible dermatologists to prescribe their products.

It would be crazy if it weren't true. There are some serious problems with the FDA that need to resolved. The ability to assess whether something is safe/effective or not is not one of them. The testing process is sound. The requirement to listen to the people who CAN assess the results, however, needs to be changed. Just for crying out loud, don't use Mercola as a source. His scientific reasoning ability is clearly questionable.

Shouldn't have said "Yawn". Better: DISGUSTING!!!

[Anonymous Coward]

The problems with corruption in the U.S. government are FAR greater than the average U.S. citizen is willing to consider.

Here is part of a transcript of a 60 Minutes segment: Dissecting Obamacare:

"Brill argues that Obamacare is the product of what he calls an "orgy of lobbying" and backroom deals in which just about everyone with a stake in the $3-trillion-a-year health industry came out ahead - except the taxpayers.

"Steven Brill: Good news: More people are gonna get health care. Bad news: We have no way in the world that we're gonna be able to pay for it.

"Steven Brill says that the outrage is what the Affordable Care Act doesn't do.

"Steven Brill: It doesn't do anything on medical malpractice reform. It doesn't do anything to control drug prices. It doesn't do anything to control hospital profits.

"Lesley Stahl: So all the cost controlling side of this just went by the wayside?

"Steven Brill: 99 percent of it."

#1 Best Seller: America's Bitter Pill: Money, Politics, Back-Room Deals, and the Fight to Fix Our Broken Healthcare System.

Posting anonymously because so many people don't want to hear how bad things are, and instead become angry at the messenger.

Science for Sale

[Anonymous Coward]

This is news, but it isn't new. There's a great book by former EPA researcher Daniel Lewis called "Science for Sale", which documents in scary detail how you can get HIV from a fellow patient at your dentist's office by means of the drill motor, or infected during a colonoscopy with stuff from the previous patient even after the equipment is supposedly sterilized, and many other hugely problematic issues that a) are scientifically documented and b) don't affect very many people directly, so they're easy to keep quiet.

The more of this kind of thing that comes to light, the better, as unpleasant as it may be. Knowledge is he only thing that can really guard us, since the government regulators either lack funding or are in collusion with industry.

Yeah, great idea

[Kludge]

Relying on the open/wiki opinion of every Tom, Dick, and Harry is much better than using objective scientific blinded clinical trials. Yeah, that will work.

The FDA does not do drug development

[Kludge]

Apparently you are under the misguided perception that the FDA does drug development. That is incorrect. The FDA does product evaluation, which is something that private industry only does because they are forced to. And I can tell you that there is no collection of scientists in the world who know more about product evaluation than there are at the FDA.

Nice hack job.

[Kludge]

This article reads like the hack job that it is.

So as part of my investigative reporting class at New York University, my students and I ...

Something tells me that these people do not know a lot about science or drug evaluation, but do know a lot about trying to make a big splash with an article that "exposes" wrongdoing.

Here's a small dose of reality: All studies and clinical trials have things wrong with them. Everytime I read a study in JAMA and the NEJM, I can point out half a dozen things that should have been done differently. When evaluating whether a drug or procedure or implant is effective you always have to read these studies with a critical eye, and consider all the evidence (laboratory, clinical, statistical, etc.) when making a decision.

The fact that some "investigative reporting" students found problems with clinical studies is hardly surprising given how many details the federal government regularly documents and records.

Re:Nice hack job.

[Anonymous Coward]

Something tells me that these people do not know a lot about science or drug evaluation, but do know a lot about trying to make a big splash with an article that "exposes" wrongdoing.

This is hardly an exposition, articles like this have been in the press for at least a decade. No one seems to care that yet another government agency is caught being openly corrupt and the articles fade away for a couple of years before resurfacing.

Re:Don't crucify the FDA. They came out long ago..

[Anonymous Coward]

Are you kidding me? Did you read where that came from? ...
  There are some serious problems with the FDA that need to resolved. The ability to assess whether something is safe/effective or not is not one of them. The testing process is sound.

Your uncited claims disagree with what the FDA claims about itself. I don't see why you couldn't just follow the information available in the link and verify for yourself. Here is what I found at the OPs link:

In November 2007, a 60-page report titled “FDA Science and Mission at Risk” was released by the FDA. In this report, the agency admitted that it lacks the competency and capacity to keep up with scientific advances.

I simply googled the provided name of the report. There I found:

The Subcommittee found that the FDA lacks sufficient expertise in quantitative methods, such as statistics and biomathematics, to effectively assess products and guide sponsors to design valid and informative studies.

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

So you are incorrect, OP is correct. Stop incompetently defending "scientific reasoning".

YES

[Anonymous Coward]

Yes!

See https://www.youtube.com/watch?v=uTmfwklFM-M

So much for 'unproven' alternatives

[Nona Slashdottir]

It always amazes me to read the many derogatory comments on Slashdot about food supplements and other alternative health approaches, with arrogant snides about how these are 'unscientific' and 'unproven', and how dumb people must be to believe the claims. Believing pharma research results seems at least as dumb (as it seems to have little or nothing to do with actual science and I think this has been obvious for many years now).

What's next?

[Anonymous Coward]

Wait until the apparatus takes control of the internet.

Re:Don't crucify the FDA. They came out long ago..

[umafuckit]

One reason they can't tell is because the data are often crooked and the pharma industry has a lot tricks up its sleeve to manipulate the apparent effectiveness of a drug. One of their mainstays is not publishing results that indicate the drug failed to work.

Re:Don't crucify the FDA. They came out long ago..

[Anonymous Coward]

Yes, that is a failure of NHST, it is totally useless in the face of any kind of p-hacking. This problem is not at all limited to the FDA-industry relationship. They need to get rid of this null hypothesis approach and demand that there is some kind of precise prediction that matches future data. They also need to write down specifically what assumptions need to hold for their interpretation of the data to be valid and then check these assumptions.

If that is too hard, that means we only have a rudimentary understanding of the human body and shouldn't be declaring drugs effective or not anyway.

But be sure to get any and all injections they say

[Agent0013]

But we still should all go out and get every damn flu shot that they say we should. Because even though there is fraud, it is still very sound science and there is no fraud going on. Their trust is and always will be at the highest levels. And if you don't have the required levels of trust then you must report for your social mind reconfiguration training.

Thank you citizens!