By TLB Contributor: Paul Fassa
After considerable pressure from independent health journalists, researchers, statisticians, and some MDs, finally the World Health Organization (WHO) responded positively.
Now the WHO is proposing public access to all drug trial papers.
Why is this important? Because by the time a study is completed, all the reports are often collated and edited to offer only the most glowing parts of the trial outcomes while hiding adverse event reports.
Sometimes pharmaceutical companies will hire ghost writers to put that final report together and pay a physician to sign off on it as though he or she had written it. The final report is what gets submitted to a medical journal, peer reviewed, and sent to everyone in the medical field showing great results with minimal or no adverse effects.
Then it becomes FDA approved, for a fee from the pharmaceutical company, and it goes to market where the reports hidden or swept under the rug manifest as serious adverse effects and deaths among many consumers over several years, during which the patent holding drug company rakes in the bucks while real-life casualties add up, class action suits are filed, and whatever losses are incurred from these suits are easily absorbed by Big Pharma as merely the costs of doing business.
Remember Vioxx, the Popular Pain Killer That Caused Heart Attacks?
Merck’s pain killer Vioxx was an excellent example. After several years of profiting grandly while many who used Vioxx had heart attacks that killed several, Merck finally pulled it off the market and settled all its lawsuits for 4.9 billion dollars. Let the reality of that billions amount sink in. Still, they managed to profit from this killer drug that was promoted and advertised heavily on TV (“ask your doctor …”).
By the time consumers started bugging their doctors to write a prescription for Vioxx, the drug reps had visited doctor’s offices with free samples and luncheons to add to the massaged journal report, which minimized or excluded adverse episodes while exaggerating positive results.
The USA and New Zealand are the only nations that allow pharmaceuticals to be advertised on TV, by the way. Medical marketing is as obscene as Big Pharma’s profits and the reported death tolls from “properly prescribed pharmaceuticals” that range from 100,000 to 300,000 annually. These estimates are from studies done within the medical field.
Concerns from Within the Medical Field
Criticisms of drug trial reports have been mounting here in the USA, the UK, EU and other regions ever since Dr. Marcia Angell, MD, asserted after resigning from her position as editor-in-chief of the prestigious New England Journal of Medicine in 2000 with this statement:
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
Dr. Angell went on to author a groundbreaking book on the pharmaceutical industry: The Truth About the Drug Companies: How They Deceive Us and What to Do About It. She also wrote an article in the New York Review of Books called “Drug Companies & Doctors: A Story of Corruption”. Here’s an excerpt from that article:
No one knows the total amount provided by drug companies to physicians, but I estimate from the annual reports of the top nine US drug companies that it comes to tens of billions of dollars a year. (…) Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease.
Other Influences That Have Led to the WHO’s Proposal
During NPR’s coverage of the Vioxx debacle, Dr. Catherine DeAngelis, an editor with the Journal of the American Medical Association (JAMA) asserted, “What people should learn from this is you don’t believe anything, not one thing, put out by a pharmaceutical company. Just don’t believe it. You start from there.”
Dr. DeAngelis went on to explain that with Merck’s record breaking funded marketing campaign, 90% of those who took Vioxx didn’t need it or it wasn’t effective for them. The benefit to risk was very upside down as proven by the number of casualties from …
Vioxx: Around 60,000 deaths worldwide from heart attacks and strokes over just under a five year period.
Merck claimed that adverse side effects only started after 18 months after beginning its use. But the New England Journal of Medicine took a closer look and determined adverse side effects had started immediately after using Vioxx.
Here’s the Clincher and the Solution
It’s called ClinicalTrials.gov, a service of the U.S. National Institutes of Medicine (NIH). It’s the repository for all clinical and drug trial reports. It’s not considered an open publication the way medical journals are.
But that’s where ongoing trials send their reports before drug companies compile, collate, and massage the final journal report to be more favorable than the ClinicalTrials.org reports. The FDA now requires all reports on human trials to be registered there.
A study published in 2014 by the Annals of Internal Medicine (AnnInternMed) compared ClinicalTrials reports and final journal reports on a sampling of drug trials and proved all that was pointed out in this article statistically.
Here’s that study’s conclusion:
“Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication [journal report].”
You can review that study abstract for the exact numbers here. If you want to see the true reports behind a Big Pharma drug’s hyped smoke screen, visit and explore the ClinicalTrials site here.
The WHO recommendation is sure to be challenged by Big Pharma just as the WHO announcement regarding glyphosate as a “possible carcinogen” is being challenged by Monsanto. But it appears the time has begun to start weakening the grip Big Pharma has on medicine. Contribute to this movement by shunning pharmaceuticals and going with natural remedies.
Paul Fassa is a contributing staff writer for REALfarmacy.com and a TLB contributor. His pet peeves are the Medical Mafia’s control over health and the food industry and government regulatory agencies’ corruption. Paul’s valiant contributions to the health movement and global paradigm shift are world renowned. Visit his blog by following this link and follow him on Twitter here.
TLB recommends you visit REAL farmacy for more pertinent articles and information.
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