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Adverse Drug Reactions Cover-Up? 80,000 Drug Files Go ‘Unreported’ by Big Pharma

Lisa Garber
By Lisa Garber
Posted On July 2, 2012

Adverse Drug Reactions

It’s not news to say that the medical industry isn’t much interested in our health. Now, wealth – that’s something different, as we’ve seen in the ties between the DSM-5 panel members and pharmaceutical companies and the disease machine that is the cancer research industry. Roche and Genentech, a Swiss-based pharmaceutical hotshot and its US affiliate, respectively, were just caught with their pants down and 80,000 unreported drug files during an inspection is, therefore, not outlandish. Could these 80,000 files be adverse drug reactions?

Adverse Drug Reactions? Tens of Thousands Dead

The files in question reported on patients taking various drugs, and it’s unclear whether all 80,000 reports—or any—regard adverse drug reactions (ADRs). Pharmaceutical companies are legally bound to notify regulatory authorities of adverse drug reactions, but one European Medicines Agency spokeswoman told New Scientist, “They are not necessarily ADRs.”

The EMA probed Roche after UK regulators found insufficient reporting of adverse drug reactions. (They came to this conclusion after another series of inspections, a coordinated European program to inspect the pharmaceutical industry’s safety reporting systems.) At its most recent count, Roche failed to submit 80,000 reports of medicines marketed in the US—reports that recorded 15,161 patient deaths. It’s unclear whether they died due to natural disease progression or drug administration.

Nearly a week after the EMA revealed the discovery on 21 June, Roche reassured the EMA with an action plan for the timely submissions of future reports.

It’s important to note that adverse drug reactions differ from drug side-effects. ADRs are always negative and can occur at any time with normal dosage, while side-effects technically involve beneficial effects. Of course the vast majority of side-effects induced by pharmaceutical drugs are very negative, with the average drug label containing 70 negative side-effects. In one of the most bizarre cases, a woman began growing fingernails instead of hair all over her body after taking an asthma drug.

Big Pharma

Natural Society wrote on the cancer industry’s equally shady behavior last year, when the Mayo Clinic declared that the last ten years’ worth of cancer research was moot due to fraud.  In example, Boston University’s Sheng Wang’s cancer research contained altered results as well as misconduct. The psychiatric community is little better, with 70 percent of panel members for the fifth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM) having financial relationships with pharmaceutical companies.

“To us, science is personal,” Genentech claims on their website.  But, really, personal check personal, right?  Because no one working for Roche buried reports of 15,161 patient deaths to mourn in private.

Additional Sources:

Newscientist

Pharmalot

Gene.com


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