FDA approval of medical devices based on complete science fraud

(NaturalNews) The Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) have both published papers criticizing the way in which the Food and Drug Administration (FDA) approves medical devices. Citing a lack of legitimate safety and effectiveness studies, the papers allege that the FDA is approving medical devices without proper scientific evidence proving that they work and will not harm patients.

Researchers from the University of California, San Francisco, pored over seven years worth of FDA public summaries concerning approved medical devices. Researchers from Beth Israel Deaconess Medical Center in Boston wrote the AJT piece, concluding that the FDA's safety and effectiveness data for medical devices is inconsistent and unreliable. William Maisel, one of the researchers, indicated that the FDA needs to improve its clinical trial standards for medical devices.

When drugs are approved, they typically go through a series of studies prior to even being evaluated by the FDA. A medical device, however, can be approved based on the results of a single study which may or may not contain important specifics such as who participated in the study. Critics note that, since a medical device is usually a permanent addition to someone's body, it deserves even more intense scrutiny than prescription drugs which can be discontinued if found to be harmful. This is especially true with heart devices that are necessary in order to keep a person alive.

Dr. Jeffrey Shuren, acting director of the FDA's device division and co-author of one of the studies, conceded that the FDA's process for evaluating medical devices is inadequate. He explained that the FDA is working on creating stronger standards for evaluation and approval but that device manufacturers need to work more closely with them to establish study goals.

Janet Trunzo, an executive vice president of AdvaMed, an advocacy group for the medical device industry, defended the FDA's current approach to approving medical devices. She expressed that device manufacturers submit extensive data to the FDA who spends 1,200 hours reviewing it all prior to approving a device.

Many approved medical devices have been recalled over the years for safety reasons. The FDA maintains a list of the most serious medical device recalls for which the products in question may cause "serious health problems or death." There are over 30 devices on the list from 2009 alone. Since 2004, there have been 137 medical devices recalled by the FDA.

Sources for this story include: http://online.wsj.com/article/SB126... http://www.fda.gov/MedicalDevices/S...

Big Pharma researcher admits to faking dozens of research studies for Pfizer, Merck (opinion)

(NaturalNews) It's being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer's speakers' bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.

Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as "proof" that Celebrex helped reduce pain during post-surgical recovery. There's only one problem with all this: No patients were ever enrolled in the study!

Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.

It wasn't the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.

As a result of Dr. Reuben's faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 "scientific" papers authored by Reuben.The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.

After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.

He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years. (http://www.theday.com/article/20100...)

Business as usual in Big Pharma

What's notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It's not the fact that so-called "scientific" medical journals published his fabricated studies. It's not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.

The real story here is that this is business as usual in the pharmaceutical industry.

Dr. Reuben's actions really aren't that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.

Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn't operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.

Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben's faked studies even though this journal claims to be a "scientific" medical journal based on peer review. Funny, isn't it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.

Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on "good science." It's all scientific and trustworthy, they claim, while accusing alternative medicine of being "woo woo" wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that's based largely on fraudulent research, bribery and corruption.

You just have to laugh, actually, when you hear pushers of vaccines and pharmaceuticals claim their medicine is "scientific" while natural medicine is "unproven." Sure it's scientific -- about as scientific as the storyline in a Scooby Doo cartoon, or as credible as the medical license of a six-year-old kid who just received a "let's play doctor" gift set for Christmas. Many pharmaceutical researchers would have better careers as writers of fiction novels rather than scientific papers.

For all those people who ignorantly claim that modern pharmaceutical science is based on "scientific evidence," just give them these three words: Doctor Scott Reuben.

Drug companies support fraudulent research

Don't forget that the drug companies openly supported Dr. Scott Reuben's research. They paid him, in fact, to keep on fabricating studies.

The drug companies claim to be innocent in all this, but behind the scenes they had to have known what was going on. Dr. Reuben's research was just too consistently favorable to drug company interests to be scientifically legitimate. If a drug company wanted to "prove" that their drug was good for some new application, all they had to do was ask Dr. Reuben to come up with the research (wink wink). "Here's another fifty thousand dollars to study whether our drug is good for post-surgical pain (wink)."

And before long, Dr. Reuben would magically materialize a brand new study that just happened to "prove" exactly what the sponsoring drug company wanted to prove. Advocates of western medicine claim they don't believe in magic, but when it comes to clinical trials, they actually do: All the results they wish to see just magically appear as long as the right researcher gets paid to materialize the results out of thin air, much like waving a magician's wand and chanting, "Abra cadabra... let there be RESEARCH DATA!"

Shazam! The research data materializes just like that. It all gets written up into a "scientific" paper that also magically gets published in medical journals that fail to ask a single question that might exposed the research fraud.

I guess these people believe in magic after all, huh? Where science is lacking, a little "research magic" conveniently fills the void.

The whole system makes a mockery of real science. It is a system operated by criminals who fabricate whatever "scientific evidence" they need in order to get published in medical journals and win FDA approval for drugs that they fully realize are killing people.

What is "Evidence-Based Medicine?"

The fact that a researcher like Dr. Reuben could so successfully fabricate fraudulent study data, then get it published in peer-reviewed science journals, and get away with it for 13 years sheds all kinds of new light on what's really behind "evidence-based medicine."

The recipe for evidence-based medicine is quite simple: Fabricate the evidence! Get it published in any mainstream medical journal. Then you can quote the fabricated evidence as "fact!"

When pushers of pharmaceuticals and vaccines resort to quoting "evidence-based medicine" as their defense, keep in mind that much of their so-called evidence has been entirely fabricated. When they claim their branch of toxic chemical medicine is based on "real science," what they really mean is that it's based on fraudulent science but they've all secretly agreed to call it "real science." When they claim to have "scientific facts" supporting their position, what they really mean is that those "facts" were fabricated by criminal researchers being paid bribes by the drug companies.

"Evidence-based medicine," it turns out, hardly exists anymore. And even if it does, how do you know which studies are real vs. which ones were fabricated? If a trusted, well-paid researcher can get his falsified papers published for 13 years in top-notch science journals -- without getting caught by his peers -- then what does that say about the credibility of the entire peer-review science paper publishing process?

Here's what is says: "Scientific medicine" is a total fraud.

And this fraud isn't limited to Dr Scott Reuben, either. Remember: he engaged in routine research fraud for 13 yearsbefore being caught. There are probably thousands of other scientists engaged in similar research fraud right now who haven't yet been caught in the act. Their fraudulent research papers have no doubt already been published in "scientific" medical journals. They've been quoted in the popular press. They've been relied on by FDA decision makers to approve drugs as "safe and effective" for widespread use.

And yet underneath all this, there's nothing more than fraud and quackery. Sure, there may be some legitimate studies mixed in with all the fraud, but how can we tell the difference?

How are we to trust this system that claims to have a monopoly on scientific truth but in reality is a front for outright scientific fraud?

Keep up the great work, Dr Reuben

Thank you, Dr Scott Reuben, for showing us the truth about the pharmaceutical industry, the research quackery, the laughable "scientific" journals and the bribery and corruption that characterizes the pharmaceutical industry today. You have done more to shed light on the true nature of the drug industry than a thousand articles on NaturalNews.com ever could.

Keep up the good work. After paying your fine and serving a little jail time, I'm sure your services will be in high demand at all the top drug companies that need yet more "scientific" studies to be fabricated and submitted to the medical journals.

You may be a dishonest, disgusting human being to most of the world, but you're a huge asset to the pharmaceutical industry and they need you back! There are more studies that need to be fabricated soon; more false papers that need to be published and more dangerous drugs that need to receive FDA approval. Hurry!

Because if there's one place that extreme dishonesty is richly rewarded, it's in the pharmaceutical industry, where poisons are approved as medicines and fiction is published as the truth.

Sources for this story include:
http://www.nbcconnecticut.com/news/...

http://blogs.wsj.com/health/2010/01...

http://www.medpagetoday.com/PublicH...

http://www.theday.com/article/20100...

Shorty Awards continues discredited contest, allows hate speech from jackals who attack natural medicine

(NaturalNews) It's been two days since the Shorty Awards fraudulently deleted the votes from all NaturalNews readers and deleted the Health Ranger as a candidate in the health category. Dr. Joseph Mercola is now in the position as the most likely candidate to potentially beat the vaccine-pushing nominee and her supporters who have resorted to some of the most vile hate speech you've ever seen on the 'net.

As I once was, Dr. Mercola is now being defamed, slandered and attacked with utterly false accusations in the voting contest -- and the Shorty Awards continues to allow all this! The dishonorable individuals from the vaccine-pushing camp are now accusing Mercola of voting fraud, trying to get him kicked out of the contest in the same way they managed to get me kicked off. I know for a fact that the accusations being leveled against Mercola are entirely false. I also know this kind of cheating is very typical behavior from vaccine pushers.

Dr. Mercola explained the situation himself in a Facebook post, "An arrogant group of science bloggers that have vilified me for the past few years have started a campaign to have an Australian shill to win a health award on Twitter. This overweight non-physician has arrogantly bashed nearly every alternative therapy and encourages reliance on drugs."

That's why NaturalNews continues to support Dr. Mercola to win the health category. Please vote for Dr. Mercola right now at: http://shortyawards.com/mercola

This is a vote for health freedom. It is a vote against the vaccine-pushers who are the enemies of health and advocates of drugs, chemotherapy and vaccines.

The Shorty Awards fraud explained

If you look at the false claims of vote fraud from the vaccine-pushing opposition, it's all quite hilarious. They accused myself and Dr. Mercola of "breaking the rules" simply because many of our supporters wanted to vote for us so badly that they created their own new Twitter accounts so they could vote!

According to the Shorty Awards rules, votes from newly-created Twitter accounts won't be counted. No problem there. We agree with the rule. Take all the votes for a candidate and simply discount any votes from newly-created Twitter accounts.

But what the Shorty Awards did to myself and NaturalNews readers is they deleted ALL our votes, including legitimate votes from existing Twitter accounts, just because some other people created, on their own, new Twitter accounts out of a desire to try to participate. According to Shorty Awards rules, these votes would simply ignored. This is NOT grounds for removing a candidate and deleting all the votes for a particular candidate.

We've done a little investigation here at NaturalNews, and we've found that virtually all the top nominees in every category of the Shorty Awards have received multiple votes from newly-created Twitter accounts, and this includes the #1 nominee in the health category right now, the shill from Australia who is being fronted by vaccine pushers who mostly don't even know who she is.

What the Shorty Awards has done is selectively decided to disqualify only the Health Ranger for votes that have been cast for EVERY nominee in the top five. And that's where their fraud comes into play. As the organizers of an award contest, they have a professional obligation to apply their rules in a fair and consistent way. This is what they failed to do, and this is why the news about the Shorty Awards losing credibility is now spreading like wildfire across the 'net.

And now -- this gets even better -- these people are creating new accounts on Facebook, then posting violent rantings on my Facebook page while complaining to Facebook to have our account removed for "promoting violence." They are the ones promoting the violence, of course.

You can probably tell by now that these jackals are front-men for Big Pharma. I've seen this behavior enough to know exactly who is behind this: The drug companies and their P.R. hit men. They see natural health advocates as a threat to their business, and they will do anything to try to get you censored, banned, disqualified or otherwise shut down on the 'net. The one thing they absolutely cannot stand is for health freedom advocates to have a voice and tell people the truth about why they don't need pharmaceuticals, mammograms, vaccines and chemotherapy.

Vote for Dr. Mercola and Kevin Gianni

There are only a few short days left before the Shorty Awards nominee voting ends. We want to help natural health advocates win this category. You can help by casting TWO votes right now (yes, you can legitimately vote for more than one candidate in the same category, according to Shorty Awards rules).

Vote for Dr. Joseph Mercola here:
http://shortyawards.com/mercola

And vote for Kevin Gianni here:
http://shortyawards.com/kevingianni

You know Kevin Gianni. He's got a huge Twitter following, and he's all about health freedom. He's standing up for health freedom by joining the race. With your support, we could potentially help Dr. Mercola take first place, and Kevin Gianni could take second or third.

Don't create a new Twitter account to cast your vote, because that's a wasted vote anyway. And the Shorty Awards, it turns out, lies about how they handle these things. Rather than merely discounting votes from newly-created accounts, they malicious disqualify whoever they want.

Your support in all this is greatly appreciated. As you can now tell, this is no longer about me winning the award, as I've been shoved out of the competition. This is about making sure that health freedom advocates are victorious over the vaccine-pushing jackals who have essentially hijacked the Shorty Awards contest because they couldn't stand the sight of a natural health advocate fairly and honestly winning this contest.

Read my previous report about the Shorty Awards here:
http://www.naturalnews.com/028006_S...

That story also reveals the contact information where you can tweet or email your complaints to the Shorty Awards organizers.

Pfizer caught in yet more science fraud: Company altered study findings for Neurontin drug

(NaturalNews) Research into internal company documents has revealed that Pfizer Inc., the world's largest research-based pharmaceutical company, tampered with the results of at least 16 study reports about its epilepsy drug, Neurontin. In order to expand the market for the drug, Pfizer unlawfully removed, altered, and changed published study findings that revealed unfavorable results.

Of the 20 study reports that were produced, eight of them were not published in medical journals at all and another eight had their original study designs altered in some way in order to arrive at alternate outcomes. Some of the primary outcomes were changed to new ones while others were replaced by secondary outcomes. Still others were simply removed altogether.

The scheme of off-label prescribing

Pfizer practices a strategy that most, if not all, drug companies employ. Following the approval of one of their drugs for a specific use, drug companies will continue sponsoring clinical trials on other possible uses in order to expand their drug market. Though not technically allowed to market their drugs for unapproved uses, drug companies will distribute information to medical professionals about the results of these additional studies that favor expanded drug uses.

In order to arrive at favorable results, industry-funded research trials are often altered, forged, and manipulated to suit the cause, as was the case with Pfizer.

When Pfizer was sued back in 2004 for illegally promoting Neurontin, it settled the case for $430 million. Expert witness Kay Dickersin of Johns Hopkins University was able to obtain the documents revealed in her study while serving for the case. Just last year, Pfizer was sued again using the original case as well as being accused of manipulating study data.

If a drug company wishes to change the goal of a particular study once it has begun, it must be done formally through an official amendment. The fact that most of the time this does not happen indicates that deceitful activity is taking place.

Dickersin suggests mandatory submission of study protocols and primary endpoints when companies register clinical trials in the public database. This will help to hold the drug companies accountable for their undertakings and eliminate the tendency to alter data through dishonest means.

Drug companies should also continue to be prosecuted to the full extent of the law for their violations. Harsher penalties for blatant violations should be implemented in order to reign in the violators and restore the integrity of the clinical trial process.

Sources for this story include
http://abcnews.go.com/Health/wireSt...

"BPA-free" foods found to contain BPA

(NaturalNews) A recent analysis of canned foods revealed that, across the board, the cans contained measurable levels of bisphenol A, also known as BPA, a toxin known to cause hormonal problems, sexual dysfunction, cancer, and other abnormalities. Even among products labeled "BPA-free", tests revealed levels of BPA significant enough to cause problems.

Released by the Consumers Union, a non-profit organization in charge of publishing Consumer Reports, the report adds fuel to the fire in the growing opposition to BPA's use in food products. Consumer advocacy groups are demanding that the FDA ban BPA from being used in any products that come into contact with food and beverages.

For years, the FDA has denied that BPA is dangerous, basing its non-concern upon flawed studies and incomplete evidence. When compelled to reinvestigate the issue, the FDA began reviewing the evidence once again. When question about the current report, an FDA spokesman had no response other than that the review was almost complete and that a "decision [about] how to proceed" would be made soon.

Manufacturers often use BPA in their food linings because it works as an effective food preservative. Yet the levels found in many of the consumer products tested were high enough to cause serious abnormalities in people, especially children.

Several supposed BPA-free items, including tuna cans that did not have the typical epoxy lining that is the primary source of BPA leeching, is concerning. It is unclear how the BPA made its way into these particular cans. Dr. Urvashi Rangan, director of technical policy at Consumers Union, believes it could have come from the factory where the product was made, from seawater, or from the fish itself. The company's owner has indicated that it will work to find the source and fix the problem.

Public outcry over the dangers of BPA has led to many manufacturers removing the additive from their product containers. Several major retailers have removed all items containing BPA from their shelves as well as six baby bottle manufacturers who eliminated the additive from their bottle ingredients last March. The city of Chicago and Suffolk County, New York, have also made provisions banning all baby bottles and other baby beverage containers made with BPA.

Thanks to consumer advocacy groups who continue to sound the alarm about the dangers of BPA, it is slowly disappearing from product labels. Hopefully, as continued investigation and exposure holds manufacturers' feet to the fire, BPA will be eliminated from "BPA-free" items as well.

Sources for this story include
http://www.latimes.com/news/nationw...