from TheFreeThoughtProject Website
Food and Drug Administration Commissioner Doctor Robert Califf
testifies at his nomination hearing in Washington, Nov. 17, 2015.
The FDA, which claims to 'protect us' from bad foods and drugs, is now run by a person who has reaped hundreds of thousands of dollars through ties to 23 drug companies.
Big Pharma has a very special privilege in the U.S., which is one of only two countries that allow direct-to-consumer marketing of its patented products.
Between this and its profit-sharing relationship with doctors, the industry has a nation hooked on legal drugs such as opioids which are killing people by the thousands and leading to a massive heroin epidemic.
To secure the approval of new patented products, Big Pharma will not hesitate to abandon scientific integrity.
Two of the biggest pharmaceutical companies,
...were just caught hiding critical laboratory data from one of the world's top medical journals.
The missing data is at the heart of a lawsuit being filed against the companies on behalf of 5,000 patients and their families who say they were harmed by the drug Xarelto, including 500 who died.
The pharma companies have a lot at stake, as the patented drug, which replaces an older drug with an expired patent, brought $2 billion in U.S. sales last year alone.
The case centers on a blood-testing device used during a clinical trial that malfunctioned, which produced faulty results that could have led doctors to favor the new drug Xarelto to the older one being used for comparison.
The trial involved more than 14,000 patients and was key to securing regulatory approval.
Duke Clinical Research Institute, which was hired by Johnson & Johnson and Bayer to carry out the trial, was even asked directly by a peer reviewer if the lab data in question existed.
They initially remained silent, but when editors at the journal rephrased the question to ask,
In fact, there was data from test results done at a central laboratory that would have been a better way to evaluate the blood-testing device.
By not using this method, the researchers had to,
Top editors at The New England Journal of Medicine, as well as Duke and pharma company spokesmen, say problems with the device did not change the trial's results.
However, some experts are not so easily convinced.
Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, was one of two members of an advisory panel to the FDA who voted against Xarelto.
He said that the device's inaccuracy means,
Duke has agreed to conduct an analysis of data from the central laboratory, but something seems fishy.
As the investigation deepens, we could see similarities to the notorious 2005 pharma scandal where Merck deleted data showing heart attacks before submitting the trial manuscript.
After this revelation, the drug Vioxx was taken off the market.
This incident highlights the impunity large corporations, who are backed by the government, enjoy. Had the average citizen negligently caused the deaths of hundreds of people, they would be the most notorious serial killer of all time.
However, since Bayer and Johnson & Johnson are a part of the corporatocracy... no one will be prosecuted...