What’s the fuss? Have any drug companies been found guilty of misrepresentation?

The pharmaceutical industry is tightly regulated, and all claims of efficacy made by their visiting reps are supposed to align with approved product information. However, even if it were the case that drug reps always restricted every claim to that allowed by their company, there are numerous instances where these claims have not only been wrong, but the companies have long known the claims are wrong.

The evidence for this comes to light when companies are found guilty of deliberate falsehoods – which their unsuspecting visiting reps then faithfully pass on to doctors. These are not small errors or honest mistakes: the massive penalties imposed by the courts prove otherwise.

The list below is not intended to demonise pharmaceutical companies who, after all, produce some of medicine’s most powerful tools for curing disease and alleviating suffering. The reason we include this section is to demonstrate that there have been repeated examples of misrepresentation and incorrect information passed off as ‘factual evidence’, which even sceptical and cautious doctors who saw reps had no way of knowing was false. The industry often suggests this is all in the past or there was one rotten apple, yet it keeps on happening.

In contrast to pharmaceutical reps, independent sources of information have no urgency to persuade doctors to use one particular brand of drug over another, so these sources tend to wait and see how the newest drugs fit into a sensible prescribing pattern.

Therefore, every instance below is a strong example of where patients of doctors who saw pharmaceutical reps were disadvantaged compared to patients of doctors who said ‘No Advertising Please’.

Information in each case below is attributable to the referenced source.

In 2009, Pfizer agreed to pay $2.3 billion dollars to settle civil and criminal proceedings alleging that they had illegally promoted their pain killer, valdecoxib. The New York Times reported that this was the “largest health care fraud settlement and the largest criminal fine of any kind ever.” (Harris)

In 2012, GlaxoSmithKline pleaded guilty to criminal charges of illegally marketing drugs and withholding safety data from U.S. regulators. They agreed to pay $3 billion. The Justice Department called it the largest health-care fraud settlement in U.S. history. They were found to be illegally promoting Aropax and withholding safety information about Avandia from the US regulator. This was the fourth time they had been found guilty in five years. (Whalen)

The Propublica website (‘Journalism in the Public Interest’) provides many further instances. These include: Merck was fined $950 million for illegally promoting Vioxx, and making false or misleading statements about the drug’s heart safety to increase sales; Johnson & Johnson agreed to pay $2.2 billion relating to illegal marketing of Risperdal and two other drugs; AstraZeneca paid $520 million to resolve allegations of illegally promoting the antipsychotic Seroquel and; Boehringer Ingelheim was fined $95 million for illegally promoting a number of drugs including Micardis, where they submitted false claims to government health care programs.

US company Purdue Pharma was fined $US634 million in 2007 for misrepresenting the addictive qualities of Oxycontin. The section ‘Promotion of OxyContin’ in the report by Van Zee provides a fascinating – and disturbing – description of how sales representatives influenced physicians to prescribe the drug for non-cancer-related pain, and it became one of the most profitable, and abused, drugs on the market. (Van Zee)

Other forms of misrepresentation include failing to report adverse effects. These include GlaxoSmithKlein’s Avanza (in which the harms were cardiovascular); Parke-Davis’s Neurontin (suppressed evidence of lack of effectiveness for bipolar disease, which the company was found guilty of promoting aggressively off-label); and Merck’s Vioxx (for which cardiovascular adverse outcomes were found to have been suppressed). (Doshi)

An article by Collier describes how, in August 2014, Novartis Japan confessed to having hidden 2,579 serious side effects cases relating to its cancer drugs Glivec, Tasigna and Afinitor, including a fatality. These serious cases were a subset of 8,697 side effects cases which the company failed to report overall. The cases were known by Novartis to have been “completely evaluated and determined to be serious and where the causality could not been denied.” (Collier)