Big Pharma buying their way out of criminal charges

Rema Nagarajan in Times of India

05 July 2012, 04:19 PM IST

The record-setting settlement has raised several questions about the system of justice. What can the $3 billion fine for GSK mean to people who have been affected adversely or have even lost loved ones because of the side effects of drugs, which GSK failed to report? Is justice served in allowing offenders to buy their way out? 

What about the people in GSK who took the decisions to not report safety concerns or to bribe doctors to push the drugs for uses not approved by the regulating agency, the Food and Drug Administration (FDA)?

The hefty fine settles criminal and civil charges of unlawful promotion of certain drugs including failure to report safety data and concerns about side effects, and for alleged false price reporting practices.

While $3 billion might be a record settlement, is it that hefty? Is it really hard on the company? Take the case of Avandia, an oral anti-diabetic, one of the drugs GSK is charged with marketing illegally. Avandia marketed since 1999 raked in over $2 billion annually. GSK is also charged with unlawful promotion of Paxil, an anti-depressant. On the market since 1994, Paxil too brought in over $2 billion annually. These two drugs alone helped GSK rake in several billions every year for over a decade. This is not even counting all the other drugs that are part of this settlement such as Wellbutrin, Advair, Imitrex, Lotronex, Flovent and Valtrex and the billions they must have earned for GSK. For being able to net sales worth so many billions, a one-time settlement of $3 billion does seem like a small price to pay to do big business.

Most major pharma companies have been accused of bribing doctors, hiding side effects of drugs and promoting drugs for uses not approved by the FDA, called off-label marketing. In 2009, Pfizer had set the record paying $2.3 billion fines for illegal marketing of 13 different drugs. In the same year, Eli Lily had to pay $1.4 billion over the marketing of Zyprexa, an anti-psychotic. Astra Zeneca and Novartis too have had to settle charges with huge fines. Over 180 pharmaceutical fraud cases, covering more than 500 drugs, are now under investigation by the U.S. Department of Justice.

Obviously, the continuing violations by pharmaceutical companies, despite such huge fines, shows that these fines are no deterrent to the companies. It is said that, to the industry, the hefty fines have simplybecome  a cost of doing business.

Director of the Public Citizen’s Health Research Group, Dr Sidney Wolfe pointed out that the settlement was nothing new for GSK, which like many pharma companies has been a repeat offender. “Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients’ lives in danger.”

In this context, unctuous statements by the US administration about the “historic” multi-billion dollar settlement being “a sign of the US government’s firm commitment to protecting the American people and holding accountable those who commit health care fraud ” merely masks the fact that companies and the executives are being allowed to buy their way out of punishment for willful and deliberate harm they cause to people.