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.