December, 16 2010, 12:16pm EDT
Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act, New Public Citizen Study Finds
Civil, Criminal Settlements Have Increased Dramatically; Off-Label Promotion Largely Responsible
WASHINGTON
The drug industry has now become the biggest defrauder of the federal
government, as determined by payments it has made for violations of the
False Claims Act (FCA), surpassing the defense industry, which had long
been the leader, according to a new Public Citizen study released
today.
The study found that pharmaceutical cases accounted for at least 25
percent of all federal FCA payouts over the past decade, compared with
11 percent by the defense industry.
The fraud results were a key finding from a Public Citizen analysis
of all major pharmaceutical company civil and criminal settlements on
the state and federal levels since 1991 and found that the frequency
with which the pharmaceutical industry has allegedly violated federal
and state laws has increased at an alarming rate. Of the 165
pharmaceutical industry settlements comprising $19.8 billion in
penalties during the past 20 years, 73 percent of the settlements (121)
and 75 percent of the dollar amount ($14.8 billion) have occurred during
the past five years.
Many of the infractions, and the single largest category of financial
penalties, stemmed from the practice of off-label promotion of
pharmaceuticals - the illegal promotion of a drug for uses not approved
by the Food and Drug Administration (FDA). Off-label promotion can be
prosecuted as a criminal offense because of the potential for serious
adverse health consequences to patients from such promotional
activities. Another major category of federal financial penalties was
purposely overcharging for drugs under various federal programs, which
constitutes a violation of the FCA.
On the state level, the largest category of financial penalties has
come from companies deliberately overcharging state health programs,
such as Medicaid. Public Citizen's study found this to be the most
common category of violation among state settlements.
The increase in payments for fraud is likely attributable to drug
companies engaging in more wrongdoing and better enforcement at the
state and federal level, said Dr. Sidney Wolfe, director of the Health
Research Group at Public Citizen.
"Desperate to maintain their high margin of profit in the face of a
dwindling number of important new drugs, these figures show that the
industry has engaged in such activities as dangerous, illegal promotion
for unapproved uses of drugs and deliberately overcharging vital
government health programs, such as Medicare and Medicaid," said Wolfe.
Wolfe compiled and analyzed the data with physicians from the Johns
Hopkins General Preventive Medicine program, Drs. Sammy Almashat and
Charles Preston, as well as Columbia University public health student
Timothy Waterman, all of whom worked at Public Citizen.
Public Citizen's study also found that more than one-half of the
industry's fines were paid by just a few companies - GlaxoSmithKline,
Pfizer, Eli Lilly and Schering-Plough. These four companies accounted
for more than half of all financial penalties over the past two decades,
paying $10.5 billion in fines collectively. These pharmaceutical
companies were among the largest in the world. The two largest criminal
penalties ever assessed by the U.S. government against any companies
were against Lilly ($515 million) and Pfizer ($1.2 billion), both in
2009.
To conduct the study, Public Citizen created a database of
information about pharmaceutical companies' civil and criminal
settlements, including information about the type of alleged violation
and the amount of money paid in settlements. This study is the first to
attempt to document and analyze all major pharmaceutical company
settlements with both federal and state governments, the authors said.
Nationally, former pharmaceutical company employees and other
whistleblowers have been instrumental in bringing to light the most
egregious violations; they have initiated the largest number of federal
settlements in the past decade. The number of federal settlements
arising from whistleblower cases has more than doubled over the past
five years, yielding total payouts more than two and a half times higher
than in the previous 15 years combined.
Needed remedies include imposing steeper financial penalties and
criminally prosecuting company leadership, including jail sentences, if
merited.
"The danger to public safety and loss of state and federal dollars
that comes with these violations require a more robust response," Wolfe
said.
To read the full report, visit https://www.citizen.org/hrg1924.
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
(202) 588-1000LATEST NEWS
Democrat Eva Burch Shares With Arizona Senate Her Plans to Get an Abortion
"I stand with those who have had to grapple with and navigate Arizona's restrictive laws surrounding abortion," the state senator said. "I'm with them. I appreciate them. I am them."
Mar 18, 2024
As Arizonans prepare for a potential vote on an abortion rights ballot measure, Democratic state Sen. Eva Burch on Monday took to the chamber's floor to announce that she plans to terminate her current pregnancy, explain why, and condemn harmful restrictions.
"A few weeks ago, I learned that against all odds, I am pregnant," said Burch (D-9). "Many of you know that I've had kind of a rough journey with fertility. I had my first miscarriage more than 13 years ago, and I have been pregnant many times. Since then, twice, I was lucky enough to successfully carry to term and I have two beautiful healthy little boys."
"But two years ago, while I was campaigning for this Senate seat, I became pregnant with what we later determined was a nonviable pregnancy. It was a pregnancy that we had been trying for, and we were heartbroken over it," she continued, referencing an abortion she has previously discussed publicly. "After numerous ultrasounds and blood draws, we have determined that my pregnancy is once again not progressing and is not viable And once again, I have scheduled an appointment to terminate my pregnancy."
"My experiences in this space, both as a provider and as a patient, have led me to believe that this Legislature has failed the people of Arizona."
Burch, who has worked as an emergency nurse and a nurse practitioner in a women's health clinic, stressed that "I don't think people should have to justify their abortions but I'm choosing to talk about why I made this decision because I want us to be able to have meaningful conversations about the reality of how the work that we do in this body impacts people in the real world."
After acknowledging some of the risks of pregnancy and that she accepted them to carry her two sons, she said: "I don't know how many of you have been unfortunate enough to experience a miscarriage before but I am not interested in going through it unnecessarily. And right now, the safest and most appropriate treatment for me and the treatment that I choose is abortion."
The Democrat then took aim at the Arizona Legislature for passing laws that restrict access to care for people like her. The state bans most abortions after 15 weeks, imposes a 24-hour waiting period between in-person counseling containing misinformation and the procedure, and forces patients to get medically unnecessary ultrasounds.
Detailing her trip to an abortion clinic on Friday, Burch said:
I didn't have an ultrasound because my doctor thought I needed one. I had one because legislation has forced me to do that, an invasive transvaginal ultrasound that I didn't want or need to have, performed by someone who didn't want to have to do it. I am safe and loved and protected in my marriage. But I cannot imagine how inappropriate that would be for a victim of sexual assault or for someone who has an abusive or coercive relationship with their partner—another unwanted vaginal penetration, but this time by the state, by the people who are commissioned to protect us.
Then I got to sit through an exhaustive list of absolute disinformation that was read off to me. I was told that there were alternatives to abortion, parenting or adoption among them, as if delivering a healthy baby is an option for me. It is not. My medical provider was forced to tell me multiple things that don't apply to my situation, and some that are just transparently factually false. And they do this because of laws passed by this Legislature in opposition to medical expert testimony and advice. From where I sat, the only reason I had to hear those things was in a cruel and really uninformed attempt by outside forces to shame and coerce and frighten me into making a different decision other than the one that I knew was right for me.
Burch explained that "the last time that I had an abortion, I started to miscarry that night before it was scheduled to take place. And I was denied a procedure in the hospital because I was deemed not critical enough, in spite of the fact that my embryo had died, and that my miscarriage had stalled."
"The clauses for emergencies aren't good enough. These laws can serve to intimidate doctors and it muddies the waters when they're trying to make complex decisions in situations that are really volatile," she argued. "I had been bleeding and passing huge clots for hours, but I wasn't bleeding out. And I was still pregnant. So I was offered medication to make me start bleeding again and told that I could have a procedure when I had bled enough. A waiting period is often totally inappropriate and potentially dangerous."
The lawmaker got an abortion at the clinic the following day—just two weeks before the right-wing majority of the U.S. Supreme Court reversedRoe v. Wade in June 2022, setting off a new wave of efforts by state legislators to pass forced-pregnancy legislation.
Burch highlighted some negative impacts of being denied an abortion—from heightened risks of domestic violence and eviction to long-term health consequences. She also noted the "sensitive feelings surrounding pregnancy" and "philosophical questions that people cannot agree on," while stressing that decisions should be made by patients and providers.
"My experiences in this space, both as a provider and as a patient, have led me to believe that this Legislature has failed the people of Arizona, in the laws that restrict and dictate abortion and in the resources that it cuts and strangles and denies at every opportunity," she said of her time in the state Senate. "Our decision-making should be grounded in expert testimony and in consensus from both the medical community and from constituents, and free from political posturing and partisan bias, but that's not what I see happening."
"So I truly hope that Arizonans have the opportunity to weigh in on abortion on the ballot in November. We know that the majority of Arizonans support the right to abortion and if we can't operate in that reality in this chamber, then it is critical that everyone have the opportunity for their voices to be heard elsewhere," she concluded. "I stand with those who have had to grapple with and navigate Arizona's restrictive laws surrounding abortion at a time when the decisions being made were complicated enough. I'm with them. I appreciate them. I am them."
Among those who praised her 10-minute speech was Sam Paisley, national press secretary of the Democratic Legislative Campaign Committee (DLCC), which works to elect state lawmakers in the party.
"Arizona Sen. Eva Burch sharing her decision to get an abortion is the epitome of courage," said Paisley. "No woman should have to go through the emotional and physical hurdles she described—Arizona Republicans have passed unnecessary burdens on abortion care that put women in danger. Sen. Burch's story is powerful, but it is sadly not unique—patients across Arizona have to jump through hoops to get the care they need."
"There are very real, and sometimes even deadly, consequences to the attacks on reproductive freedom that Republicans across the country have launched," Paisley added. "The DLCC commends Sen. Burch for her advocacy and stands ready to defeat alarming GOP extremism in state legislatures in Arizona and across the country."
Jodi Liggett, founder of the Arizona Center for Women's Advancement, similarly said on social media: "Today, Sen. Eva Burch shared her heart-wrenching story of nonviable pregnancy. AZ laws... have complicated her access to care. Her situation is one of thousands; personal and complicated. Conservatives, butt out and let patients and doctors handle these decisions. Privately."
Keep ReadingShow Less
EPA Announces 'Long-Overdue' Asbestos Ban
"Today's EPA rule to ban the use of chrysotile asbestos is a groundbreaking, landmark protection," said AFL-CIO president Liz Shuler. "Unions have been sounding the alarm on this dangerous substance for decades."
Mar 18, 2024
Labor and environmental advocates on Monday applauded the Environmental Protection Agency for finalizing a ban on the last remaining type of asbestos used in the United States eight years after Congress amended the nation's chemical safety law to accelerate the phaseout of the carcinogenic substance.
The EPA announced a final rule to prohibit ongoing uses of chrysotile asbestos, which is found in a wide range of products including asbestos diaphragms, sheet gaskets, brake blocks, and aftermarket automotive brakes and linings. In a rare display of election-year bipartisanship, Congress voted nearly unanimously in 2016 to amend the Toxic Substances Control Act to update and strengthen the nation's chemical safety laws.
"Today's rule is a positive first step to give all Americans a future free of exposure to asbestos—a carcinogen that has killed far too many."
Asbestos exposure can cause mesothelioma as well as laryngeal, lung, and ovarian cancer. Banned in more than 50 countries, the substance is linked to more than 40,000 U.S. deaths each year.
"The science is clear—asbestos is a known carcinogen that has severe impacts on public health," said EPA Administrator Michael Regan. "President [Joe] Biden understands that this concern has spanned generations and impacted the lives of countless people. That's why EPA is so proud to finalize this long-needed ban on ongoing uses of asbestos."
The Congressional Progressive Caucus said on social media that "this new asbestos ban is long-overdue and will save thousands of lives."
U.S. Sen. Jeff Merkley (D-Ore.) said in a statement that "today's rule is a positive first step to give all Americans a future free of exposure to asbestos—a carcinogen that has killed far too many."
"An immediate ban on the import of chrysotile asbestos for the chlor-alkali industry is a long-overdue step forward for public health," he added.
Liz Shuler, president of the AFL-CIO union, hailed the EPA's "groundbreaking, landmark protection," adding that "unions have been sounding the alarm on this dangerous substance for decades."
Green groups echoed labor unions in welcoming the EPA move. Environmental Working Group senior vice president Scott Faber said that "it's been more than 50 years since EPA first sought to ban some uses of asbestos and we're closer than ever to finishing the job."
"For too long, polluters have been allowed to make, use, and release toxins like asbestos and PFAS without regard for our health," Faber added, referring to per- and polyfluoroalkyl substances, commonly called forever chemicals. "Thanks to the leadership of the Biden EPA, those days are finally over."
Keep ReadingShow Less
US State Department Claims It Hasn't Seen Reports of Israel Torturing UNRWA Staff
"The U.S. cut funding to a vital aid agency during a crisis, but isn't up to speed on reports that directly impact that funding?" asked one observer.
Mar 18, 2024
A Biden administration spokesperson on Monday attempted to avoid addressing allegations by employees of the United Nations agency for Palestinian refugees that they were tortured while in Israeli detention by claiming the U.S. State Department has not seen any media reporting on the accusations.
Ryan Grim, The Intercept's Washington, D.C. bureau chief, asked deputy State Department spokesperson Vedant Patel if he believes the United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA) staff members who say they were tortured by Israeli interrogators into making false confessions about involvement with the Palestinian militant group Hamas, which led the October 7 attacks on Israel. Israeli officials claimed that at least 12 out of UNRWA's 13,000 staff in Gaza had ties to Hamas and October 7.
"The U.S. cut funding to a vital aid agency during a crisis, but isn't up to speed on reports that directly impact that funding?"
"When you originally talked about the allegations against the 12 staff, you have said that UNRWA itself was the one who forwarded those allegations alone. You said you found them credible, but since then UNRWA itself has said that its staff were tortured by Israel in order to get some of those confessions extracted," said Grim. "Does that change your view of the evidence that was presented by Israel, and if UNRWA was credible enough for you believe the allegations the first time, is UNRWA credible enough when they make an allegation of torture against its staff?"
Patel replied, "I've not seen that reporting, Ryan," adding that "we continue to find the allegations that were laid out a number of months ago to be credible."
The U.S. and more than a dozen other nations suspended funding for UNRWA in the wake of the Israeli allegations. In what UNRWA Commissioner-General Philippe Lazzarini later called an act of "reverse due process," the agency terminated nine employees in response to Israel's claims, despite admitting to having no evidence to support their firing.
The European Union and nations including Canada, Sweden, and Australia subsequently reinstated funding for UNRWA, which Lazzarini said "is facing a deliberate and concerted campaign to undermine its operations."
The controversy over UNRWA has unfolded as the agency struggles to provide shelter and humanitarian aid to Gazans, who are suffering not only Israeli bombs and bullets but also a genocidal siege and blockade that are exacerbating growing famine in the embattled enclave.
U.S. Sen. Chris Van Hollen (D-Md.) this week called Israeli claims that UNRWA is a Hamas proxy a "flat-out lie."
"If you cut off funding for UNRWA in Gaza entirely, it means more people will starve, more people won't get the medical assistance they need, and so it would be a huge mistake," the senator warned.
Keep ReadingShow Less
Most Popular