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December 27, 2010
Pharmaceutical Industry Fraud
By Ralph Nader
In the past, the Pentagon took top honors at being most effective at defrauding the government,now it's the pharmaceutical companies.
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The corporate defrauding of taxpayers (eg. Medicaid and
Medicare) and prescription drugs with skyrocketing prices was the subject of a
report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).
Dr. Wolfe's team compiled a total of 165 federal and state settlements since
1991 totaling $19.8 billion in penalties. A key finding is that the drug
industry's penalties under the Federal False Claims Act exceed even those
assessed against the overcharging defense industry for fraud.
Before we become overly impressed with the cumulative amount of the penalties,
specialists in corporate crime law enforcement believe that adding more federal
cops on the corporate crime beat, backed by a determined law and order Justice
Department with White House backing, would have greatly increased the number of
cases and imposition of penalties on these drug industry giants.
Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up
over the past five years. This is due to "a combination of increased
violations by companies and increased law enforcement on the part of federal
and state governments," says the report.
Many of these cases were initiated by company whistleblowers, who under the
False Claims Act can receive a share of the settlements. Since the corporate
bosses of these drug firms are almost never prosecuted, what these executives
fear the most are company employees who go public with the evidence of
corporate misdeeds.
These violations do more than financial damage to consumers and government
health insurance programs. One of the worst violations involves companies
promoting unproven, often dangerous uses for their medicines. Last year, Pfizer
paid $1.2 billion for illegal off-label promotion -the largest criminal fine in
U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly,
Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck,
Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest
Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.
The violations by these and other drug companies point to the wide range of
impacts, including taking many lives of patients, which stems from these
recurrent activities. These criminal or civil illegalities cover (1)
overcharging government health programs, (2) unlawful promotion, (3) monopoly
practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing
practices, (7) environmental violations, (8) financial violations and (9)
illegal distribution.
Outside the purview of the Public Citizen study are the ravages of counterfeit
drugs and poorly inspected ingredients in drugs, now mostly coming from China and India,
due to the outsourcing by U.S.
and European drug companies in their thirst for even greater profits.
Drug company sales are huge, growing from $40 billion in 1990 to $234 billion
in 2008, and far exceeding inflation with their annual price gouging. To make
matters worse, in 2003, the Congressional Republicans, with decisive support
from some Democrats, passed the drug benefit bill which explicitly prohibited
Uncle Sam, the payer, from bargaining for volume discounts with drug companies.
With over 400 full-time drug company lobbyists putting pressure on Congress,
and tens of millions of dollars flowing into the legislators' campaign coffers,
budgets for federal investigators, prosecutors and inspectors are kept to a
minimum. Unfortunately, crime in the suites pays over and over again, despite
occasional penalties.
A bright spot is the increasing enforcement action at the state level.
By last year, 32 states had enacted false claims acts, including fourteen
states that qualified as strong laws by federal standards.
Still, the Wolfe report concludes that the "current system of enforcement
is not working." He gives the examples of the $7.44 billion in financial
penalties assessed over the past twenty years on Glaxo, Smith, Kline and Pfizer, as
compared to their combined total of $16.5 billion in global net profits in one
year alone.
What would deter these illegal practices and risks to public safety? Dr. Wolfe
says "the lack of criminal prosecution that would result in jailing of
company executives." is key. Moreover, the report notes that "a
felony conviction could result in their companies becoming ineligible for
reimbursement from federal and state health programs, a critical
source of pharmaceutical company revenues."
A flicker of hope that a little change is on the way came from the Food and
Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He
indicated that the government is considering going after drug company
executives for violations such as off-label promotions. He stated:
"...unless the government shows more resolve to criminally charge
individuals-at all levels in the corporate hierarchy-we cannot expect to
make progress in deterring off-label promotion."
The problem is that the final operating decision is in the hands of the Justice
Department-historically short-staffed and short-willed to entreaties for
prosecution by the FDA and other regulatory agencies.
Furthermore, for over 30 years, the Justice Department has stone-walled
requests that it start a corporate crime database as it has done with street crimes.
Congress likes it this way, as it continues to cash corporate campaign checks.
Just last week, however, outgoing Judiciary Committee Chairman, Democrat John
Conyers introduced a bill (H.R. 6545) to create such a corporate crime data
base in the Justice Department. Well, as the saying goes, everything starts
with a gesture!
Ralph Nader is one of America's most effective social critics. Named by The Atlantic as one of the 100 most influential figures in American history, and by Time and Life magazines as one of the hundred most influential Americans of the twentieth century, his documented criticism of government and industry has had widespread effect on public awareness and bureaucratic power. He is the "U.S.'s toughest customer" says Time magazine. His inspiration and example have galvanized a whole population of consumer advocates, citizen activists, and public interest lawyers who in turn have established their own organizations throughout the country.