It’s Evidence-Based Medicine
There is evidence, of a sort: cherry-picked, manipulated and riddled with conflict-of-interest! According to world-renowned meta-researcher Dr. John Ioannidis and his team of scientists, 90% of the published information doctors rely on is flawed.1/
Ioannidis (pronounced Yo-need-eez), in going through major medical journals, was struck by how often gold-standard findings would later be retracted. Examples: mammograms, colonoscopies and PSA tests are now in disfavor; Prozac, Zoloft and Paxil, gold-star antidepressants, now heralded as no better than placebo; aspirin once a day to protect against heart attacks–now seen as ineffective and dangerous.2/
Why would this be happening? Medical journals want sensational articles. A study that’s “sensational” is going to sell the magazine. Medical journals reject 90% of submissions and being published is essential to researchers who want to keep their funding; so, the pressure is on to make an outlandish or “ground-breaking” claim and back it up by skewing the results if necessary; hence, so many “never mind!” (as they call them) articles appearing months or years later as the truth finally can’t be denied.
Ioannidis honed in on 49 of the most highly regarded research articles of the previous 13 years, only to find that almost half of them (41%) had been demonstrated to be wrong! (What you saw in a previous issue about taking an aspirin a day? Well…. “Never mind”!)
Ioannidis’ findings were published in JAMA.3/
As if to confirm this information, Glen Begley, former drug company researcher, and a team of scientists, selected 53 trial results from top medical journals and couldn’t replicate 47 of them! 4/ I’m sure you know that one of the criteria that makes for a scientific fact is something called “repeatability”. If the science is there, you can repeat an experiment and get the same result. Well, it seems that the overwhelming majority of these “studies” can’t be repeated!
So what does that mean, then? An 89% failure rate? 89% of the studies in journals are unreliable? That comports with Ioannidis’ findings that 90% of published information doctors rely on is flawed!
Again, incredibly, when biotech company, Amgen, tried to confirm 53 published journal studies, they found that they could only replicate six of them! 5/ Once again, that’s an 89% failure rate! These 53 studies had been considered “landmark”!
Unbelievably, yet again, drug company, Bayer, conducting a similar study, found that they could only confirm 25% of published studies, the majority of which had to do with cancer research.
So here’s what happens: trials start piggy-backing on the flawed studies; they become the foundation for whole new levels of research and whole new drugs and protocols! Before you know it, cancer patients are taking chemotherapy drugs predicated entirely on the faulty premise of the original trial! As recounted in the journal Nature:
“Some non-reproducible preclinical papers had spawned an entire field, with hundreds of secondary publications that expanded on elements of the original [faulty] observation….”6/
It’s just mind boggling!
It’s Been Tested
Yes, it’s been tested, alright; but, I don’t think you want to know where! It’s not what you think! Big Pharma is testing drugs mostly in China, India, Estonia, Argentina, Nigeria, Moldavia, Poland…pretty much anywhere you can find the poor, the illiterate, the unsophisticated and the uneducated. Why? You can tell them anything! (like the reason they’re there is to get medical care) and pay them next to nothing. However, since this is a wind-fall for most of these people, they’re frequently “professional drug trial volunteers”, skewing the results by being in so many trials and on so many drugs at the same time!
Of course, there’s no over-sight of trials outside of the United States, and no one cares! No one is over-seeing these trials, no government agency, not even the drug company, which has farmed the trial out to for-profit independent contractors, and they do everything! They recruit the subjects, set up the rules, conduct the trial, write the reports, ghost-write journal articles and guess what? They can do as many trials as they want until they finally get one to turn out “right”, then they can submit that trial and bury all the others that failed including all the subjects and children who died or were injured during the trial–and yes, plenty of drugs are tested on children, even babies!
Half of all clinical trials have never been published.7/
Take the popular flu drug, Tamiflu. Eight of the 10 trials done on Tamiflu have never been released by Roche.8/
As for the antibiotic, Ketek, it couldn’t be approved based on the trial done in Alabama because that trial, conducted for Aventis by Dr. Anne Kirkman-Campbell, was outed as a fraud.9/ The data from 91% of her patients were falsified! Nonetheless, the drug was approved based on the results that came in from what they call the “rescue countries”– in this case, Tunisia, Morocco, Hungary and Turkey.
After a while, reports of people suffering side effects began crossing the desks of the FDA. Eventually, FDA’s own researchers began to complain, saying 4,000 infants and children were recruited into trials for Ketek’s effectiveness in ear infections and tonsilitis and the whole thing was unethical. The internal squabble was leaking out of FDA’s tightly knit confines, there were inquiries from Congress. The day before a Congressional hearing on the Ketek matter was to start, FDA finally ordered a black-box warning to be placed on the antibiotic in 2006. By then the agency had received 93 reports of severe adverse reactions and 12 deaths.
When FDA’s chief reviewer, David Ross, explained the reasons for his objections to Ketek, he told the congressional committee that it was… “Because FDA broke its own rules and allowed Ketek on the market, because dozens of patients have died or suffered needlessly, because FDA allowed Ketek’s maker to experiment with it on children over reviewers’ protests, because FDA ignored warnings about fraud, and because FDA used data it knew were false to reassure the public about Ketek’s safety.”10/
Anne Marie Cisneros, who had been hired to monitor Kirkman-Campbell’s trial, insisted to congress that the drug company, Aventis, had not been a victim of fraud as they claimed. “What brings me here today is my disbelief at Aventis’ statements that it did not know that fraud was being committed. Mr. Chairman, I knew it, PPD knew it, and Aventis knew it.”11/
In the same vein, in the mid-’90’s, Glaxo conducted trials on Paxil. The trials showed no beneficial effects on teenagers, some of the trials showed that placebo was more effective! A Glaxo internal memo surfaced saying how important it was to “effectively manage the dissemination of these data in order to minimize any potential commercial impact. … It would be commercially unacceptable to include a statement that efficacy had not been demonstrated.”12/ Yikes!
Here’s my favorite! Astra Zeneca’s drug trial comparing Seroquel with Haldol produced an internal email in which a company executive praised the project physician by saying she had done a great “smoke-and-mirrors job” by putting a positive spin on “this cursed study.”13/ Good grief!
Wake up, everybody!
3. The FDA Is Overseeing the Whole Thing!
If by “overseeing” you mean being a rubber-stamp for Big Pharma trials, which are always favorable, then, yes, they are overseeing the whole thing!
In 2008, the FDA (which stands for the Food and Drug Administration) inspected less than 2% of trial sites inside the United States and less than 1% of trial sites outside the United States.14/ It’s also supposed to inspect drug manufacturing plants, which it also doesn’t do! Proof being the 2008 Heparin contamination scare when the FDA had no idea where the Heparin was coming from! Months and 200 deaths later, it was finally found to be coming from China!15/
The FDA is terrified of whistle-blowers. It spies on its own employees. FDA drug reviewer for 10 years, Ronald Kavanagh, says in an interview with Truth-Out, “While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. … If we asked questions that could delay or prevent a drug’s approval, which of course was our job, management would reprimand us, reassign us, hold secret meetings about us, and worse. … Sometimes we were literally instructed to only read a 100-150 page summary and to accept drug company claims without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review certain sections of the submission but invariably, that’s where the safety issues would be. … On another occasion, a company clearly stated in a meeting that they had ‘paid for an approval.'”16/
Why does the FDA act like its client is the drug industry? Because it is! What is a client but someone who pays for your services? Do you know who funds the FDA? Tax dollars? No. The drug companies! I know that’s hard to believe! David Graham, another FDA whistle-blower said in 2005, “As currently configured, the FDA is not able to adequately protect the American public. It’s more interested in protecting the interests of industry. It views industry as its client.”17/