GlaxoSmithKline, the pharmaceutical company that produces the antidepressant Paxil, created a study to prove efficacy, then falsified the results.
Dr. Tami Meraglia says, “The purpose of this study was to show this drug was an effective and safe drug to treat children and adolescents with depression.”
Meraglia, M.D. of integrative medicine, goes on to say, “The problem is that they found that was not the case. The study revealed that their emotional stability deteriorated and their suicide ideation and risk tripled.”
This is where the problem began. When the findings didn’t follow suit with their needs, GSK altered the data and made it say what they needed it to say.
Meraglia said GSK decided to, “Omit the parts that are not in favor of this drug being used to treat children and only the good parts that supported this study were published. Some of the children that were dropping out because of ideation of suicide were labeled as non-compliant rather than reported as a side effect which would have eventually proven this drug to be a bad choice.”
Study 329 was reported in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). They claimed the drug was, “Generally well tolerated and effective for depression.” They claimed Paxil was safe and effective, that the study patients showed significant improvement, that it was well tolerated and that the drug showed remarkable efficacy. The overall results were deemed positive.
GlaxoSmithKline plead guilty and paid $3 billion in fines covering fraudulent sightings on six different drugs, not just Paxil. Paxil made GSK $11.6 billion while on market.
The problem doesn’t just reside with GSK, it was also exposed with Johnson & Johnson.
Allen Jones was working as the lead fraud investigator for the Pennsylvania Office of Inspector General when he noticed the discrepancies. He said, “I discovered Johnson & Johnson was creating a drug protocol that would favor their drug Risperdal, to expand the number of uses. The entire marketing process of the drug from clinical trial through academic reporting, through the FDA and approval process, it was all based on fraudulent or manipulated material.”
Risperidone was used as an anti-psychotic specific for treating schizophrenia.
Jones put his job in jeopardy with his findings. He said, “I was told I was too focused on the big picture, back off. Drug companies write checks on both side of the aisle.” He went on to say his superiors were not happy because, “Their jobs were being supported by the political people supporting the industry.”
He did what he was told and backed off but collected data so he could blow the whistle. He collected over 10 million pages of findings. Jones says his team of attorneys along with the attorney general lawyers accumulated over 100,000 billable hours.
He said, “Johnson & Johnson caved after six days of prosecution testimony. We were destroying them, laying out an incredible story of deceit which permeated the entire drug development and marketing process.” They paid nearly $3 billion in fines and settlement payouts.
Risperdal made $44 billion overall, a $3 billion fine is just a dent of the earnings from that one drug.
Attorney Gordon Schnell said, “One of our clients found clear evidence of the fraud, writing sheets where numbers were actually crossed out.” The pharmaceutical company told Schnell’s client it was a business decision.
Merck has been shown to follow the same pattern while re-testing the competency of the mumps vaccine, which received approval in the 1960s with a 95% efficacy rate at the time.
Schnell said a couple of the Merck research scientists came to him, seeking legal counsel, after they were struggling to achieve the same 95% efficacy rate.
Schnell said, “Our clients were saying the vaccine was not working as well as it was originally. They were told by senior executives it was important to maintain that original efficacy, that very high number, so that it could be continued to be licensed in the United States. To sell the vaccine our clients were directed to falsify the data on the testing.”
Meraglia says, “The business of medicine has taken over and superimposed it’s purpose, its agenda, on medical science. The physicians no longer have access to the facts and the data that would allow us to decide what is best for our patients.”
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