Wall Street Journal reported
AKSHAT SHARMA
have to pay the US government a sum of $3 billion to settle some of
the criminal and civil investigations into whether the company
marketed some drugs illegally and defrauded the Medicaid program. The
settlement would also resolve a Justice Department probe into GSK’s
development and marketing of the diabetes drug Avandia, linked to
heart attack risks in several patients across the US. The drug was
withdrawn from all over the world last year. According to GSK, the
settlement brings to an end the eight-year-old probe into its
marketing of top-selling drugs, including the antidepressants Paxil
and Wellbutrin, between 1997 and 2004. The investigation was on
allegations that GSK promoted Wellbutrin for indications not approved
by the US FDA. Just six weeks ago, Pfizer, world’s largest
pharmaceutical company also agreed to pay $14.5 million to the US
government to resolve False Claims Act allegations related to its
marketing of the drug, Detrol. This is the last of the 10
whistleblower suits filed in the District of Massachusetts and two
other districts against the company beginning in 2003. The other nine
suits against Pfizer including the one on painkiller, Bextra, were
settled or dismissed in 2009 as part of the US government’s global
resolution with Pfizer, under which the company agreed to pay $2.3
billion to resolve civil claims and criminal charges regarding a few
other drugs. Eli Lilly and Abbott were also allegedly involved in
illegal marketing of certain drugs and had to agree to make payment to
the US government in the recent past.
Apart from the huge financial implications of these settlements, they
also caused major dents on the credibility of these top global
pharmaceutical companies. Public trust on these once prestigious drug
makers has been on the decline for some time now with increasing
instances of unethical and sometimes totally illegal marketing
practices adopted by them. Market exclusivity for products with the
help of worldwide patent protection enabled them to easily indulge in
such practices. Frequent findings of serious adverse drug reactions of
several of their approved drugs and subsequent withdrawals from the
market have further damaged their reputation. The recall of Merck’s
blockbuster drug, Vioxx, in 2004, Pfizer’s Bextra in 2005 and
Celebrex in 2009 and GSK’s Avandia in 2010 are just a few cases in
this regard. With the increasing number of drug failures in the market
the US FDA has also become extremely cautious in granting marketing
approval for new drugs. It has approved only 21 new drugs in 2010 as
against 25 in 2009. The number of new drugs approved remained in the
range of 20- 25 by the FDA during the past 4 years. What is driving
these multinational drug companies to resort to unethical marketing
activities is the fear of steady erosion in their profitability due to
patent expiries of the blockbuster drugs and increasing competition
from generics. This is at a time, the pipelines of most of top pharma
companies are not at all promising. Therefore, serious efforts are
necessary to intensify new molecular research and to bring out new
drugs for various infectious and life style diseases. Currently, there
are no drugs available to cure most of the life style diseases and
some of the infectious disease like malaria and drug resistant TB.