Posts Tagged ‘Justice Department’

JAMA: Spotty results with off-label antipsychotic use

Wednesday, September 28th, 2011

FiercePharma
By Tracy Staton
September 27, 2011

Off-label use of powerful antipsychotic drugs has come in for plenty of debate in recent years. The expensive, newer-generation “atypicals” have been used to treat dementia, depression, anxiety, post-traumatic stress disorder, dementia, attention-deficit hyperactivity disorder…the list goes on. And all this while the Justice Department was investigating Big Pharma for off-label promotion of the drugs.

An updated analysis now finds that antipsychotic drugs’ utility in off-label uses is minimal, but the risks are significant, Medscape reports. Several illnesses didn’t respond at all to antipsychotic therapy, the data showed, including eating disorders and addiction problems. The evidence for treatment of personality disorders was a toss-up. Meanwhile, side effects were sometimes severe, including weight gain, metabolic problems, fatigue, urinary tract symptoms and even an increased risk of death, the researchers said.

A few off-label uses won support from the new data. Anxiety patients got moderate benefit from AstraZeneca’s ($AZN) Seroquel, and OCD sufferers were helped by treatment with Johnson & Johnson’s ($JNJ) Risperdal. Elderly patients with dementia saw a small benefit with antipsychotic use.

“We need to use this information and be wary of prescribing when it isn’t warranted,” said Dr. Alicia Ruelaz Maher, lead author of the JAMA-published study. “I think the biggest takeaway is that instead of just prescribing blindly, we now have evidence to guide us.” And, as Maher told Reuters, “Each individual patient needs to be considered as opposed to, ‘This is good for this condition.’”

http://www.fiercepharma.com/story/jama-spotty-results-label-antipsychotic-use/2011-09-28

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Miami couple faces lengthy sentence for Medicare fraud

Wednesday, September 14th, 2011

A Miami couple who owned a South Florida chain of mental health clinics face spending the rest of their lives in prison for ripping off millions from Medicare.

Miami Herald
By Jay Weaver
September 13, 2011

From left to right: American Therapeutic Corp. senior executives Lawrence Duran, Marianella Valera, Judith Negron, Margarita Acevedo and Joseph Valdes gather at a 2009 political fundraiser in Miami for then-U.S. Senate candidate Kendrick Meek. The fundraiser was sponsored by a Washington, D.C., lobbying group, the National Association for Behavorial Health, whose members include Miami-based ATC and other mental-health clinic providers. U.S. Justice Department

Lawrence Duran was a Miami healthcare executive who regularly lobbied Congress in favor of legislation to boost government subsidies for his industry: community mental health centers. He visited with U.S. Rep. Ileana Ros-Lehtinen in Washington to drum up support. He, his girlfriend and other members of his lobbying organization threw a fundraiser for another Miami congressman, Rep. Kendrick Meek, when he ran for the U.S. Senate.

But Justice Department officials paint a far more sinister portrait of Duran and his girlfriend, Marianella Valera. They say the lobbying work was all a front to help them steal more money from the taxpayer-funded Medicare program.

Now Duran and Valera, who each pleaded guilty this year to Medicare fraud charges of running the biggest mental-health racket in the nation, face the prospect of spending the rest of their lives in prison for orchestrating the $205 million scam.

If U.S. District Judge James Lawrence King sides with prosecutors at a sentencing hearing Wednesday, Duran, 49, and Valera, 40, could be imprisoned for 50 and 40 years, respectively. Those sentences would be the longest prison terms ever for Medicare fraud offenders in the country, surpassing 30 years given to a convicted Miami doctor for her role in an $11 million HIV-therapy scheme.

Duran and Valera, who once lived together in a waterfront condo, traveled overseas and owned luxury cars, co-owned American Therapeutic Corp. Until the feds shut down the Miami-based company last October, it operated a chain of seven mental-health clinics in South Florida and Orlando that duped Medicare into paying the couple’s business $87 million during the past decade.

Their lawyers, Lawrence Metsch and Arthur Tifford, contend that they should only be held liable for that loss to the federal healthcare program — not the $205 million in fraudulent claims their company submitted to Medicare.

The loss amount, depending on how the judge rules, will be a major factor in their sentencings.

In the past year, Duran and Valera were charged along with 32 other American Therapeutic employees, psychiatrists, counselors, nurses, marketers, patient recruiters and others who supplied Medicare beneficiaries in exchange for kickbacks. American Therapeutic billed Medicare for thousands of patients, including many with dementia and Alzheimer’s disease, who had no way of benefiting from the company’s costly group-therapy sessions, prosecutors said.

Duran and several of the employees also held “charting” parties, where they would falsify the medical records of beneficiaries to make it look like they needed therapy when they actually didn’t.

About a dozen of the defendants have been convicted, including Duran and Valera’s top aides, Margarita Acevedo, who ran the marketing operation to bring in patients, and Judith Negron, who was in charge of a subsidiary, MedLink, which laundered Medicare profits to pay employees and kickbacks. Another employee, Joseph Valdes, who worked under Acevedo, also pleaded guilty.

Justice Department lawyers are seeking such an extraordinarily high sentence for Duran partly because of his role as a board member of the National Association for Behavioral Health. The Washington, D.C. coalition was established to lobby Congress on behalf of clinics that purportedly provided services to the mentally ill, prosecutors said.

The group’s brochure said it was founded in 2006 with the “express purpose of fighting what would have been devastating cuts to” community mental-health centers, such as Duran’s business, American Therapeutic.

In October 2009, Duran authored a letter to the mental health operators nationwide, expressing concern about the closure of some community clinics, Medicare’s heightened scrutiny of payments and future reimbursement rates.

“We must continue to work together to protect the benefit and our patients who so desperately need our services,” Duran wrote.

The Justice Department, however, said in court papers that the organization aided Duran’s criminal conspiracy, which resulted in Medicare millions for his business, co-owned with Valera, a licensed mental-health counselor.

Little of that money has been recovered by the FBI, Health and Human Services and Internal Revenue Service.

“In actuality, NABH was an organization that provided Duran a legitimate-looking vehicle to lobby Congress to allocate more money, through Medicare, to Duran and his co-conspirators for their fraudulent claims,” Justice Department lawyer Jennifer Saulino wrote in a recent court filing.

“He directed NABH staff to disseminate to other [community mental health centers] the tricks of his trade,” Saulino wrote, noting how he instructed others “on ways in which to win appeals of Medicare denials of claims, based on ATC’s experience.”

Duran’s company also wrote four checks to NABH totaling $49,500.

Last week, another Miami member of the lobbying organization, Biscyane Milieu Health Center, was implicated in an indictment charging its owners and about 20 others with Medicare fraud.

The organization sponsored a Miami political fundraiser for Meek in October 2009, because he was an advocate for the mentally ill and supported President Barack Obama’s healthcare reform legislation.

As part of their bid to boost Duran’s prison sentence, prosecutors filed a picture of him with Valera, Negron, Acevedo and Valdes at the Meek fundraiser.

A former Meek campaign aide told The Miami Herald that the congressman did not solicit the support of Duran’s lobbying organization. Rather, a Meek supporter knew Duran and coordinated the group’s fundraiser for the congressman, who went on to win the Democratic primary for the U.S. Senate but lost in the general election last year.

“Congressman Meek met Duran for the first time at the fundraiser,” said the former aide.

Read article here:  http://www.miamiherald.com/2011/09/13/v-fullstory/2405602/miami-couple-faces-lengthy-sentence.html

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In shift, feds target top execs for health fraud

Tuesday, May 31st, 2011

Associated Press
May 31, 2011

Lewis Morris, general counsel for the Department of Health and Human Services inspector general, poses for a portrait in his office in Washington, Thursday, May 26, 2011. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.

The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.

Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.

Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.

The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.

“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes & Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”

Others say high-powered corporate targets won’t go meekly.

“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”

Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.

Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.

A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.

The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”

Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.

The company said it had considered the case closed. But then came the inspector general’s letter.

“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”

Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”

Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.

The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.

It’s making an entire industry nervous.

Read article here:  http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

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WSJ: Feds want $1B settlement in J&J Risperdal probe

Friday, May 13th, 2011

FiercePharma
By Tracy Staton
May 13, 2011

Johnson & Johnson could be on the hook for about $1 billion to settle the government probe into its Risperdal marketing. Prosecutors are looking for a settlement about that size, the Wall Street Journal reports, citing sources. That would be the third-largest marketing settlement between a Big Pharma company and the U.S. government; only Pfizer and Eli Lilly have made larger deals with the feds.

Earlier this week, J&J disclosed to the SEC that it had set aside an unspecified amount to cover a potential Risperdal settlement. The company had already taken a $1.4 billion charge against first-quarter earnings to cover legal costs.

The WSJ says J&J officials were surprised that prosecutors were pressing for such a large settlement. Prosecutors are trying to put a settlement of Risperdal marketing claims into context, using as a benchmark Lilly’s $1.4 billion deal to resolve a Zyprexa marketing probe. The difference between the two was that Lilly’s alleged violations extended over a longer period of time, the WSJ source said. The particular allegations against J&J haven’t been disclosed.

The Justice Department has settled a number of marketing cases against Big Pharma over the last several years, and the pace of those deals increased last year. Drugmakers together have paid more than $10 billion to settle government probes; in 2010, the industry’s whistleblower settlements topped the Justice Department charts.

Read article here:  http://www.fiercepharma.com/story/wsj-feds-want-1b-settlement-jj-risperdal-probe/2011-05-13

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First Miami defendant in nation’s biggest mental healthcare fraud case pleads guilty

Thursday, April 14th, 2011

Note from CCHR:  Governments and private health insurance companies have provided the mental health industry with billions of dollars every year to treat “mental illness,” only to face industry demands for even more funds to improve the supposed, ever-worsening state of mental health. No other industry can afford to fail consistently and expect to get more funding.  A significant portion of these appropriations and insurance reimbursements has been lost due to financial fraud within the mental health industry, an international problem estimated to cost more than a hundred billion dollars every year.

  • The United States loses approximately $100 billion to health care fraud each year. Up to $20 billion of this is due to fraudulent practices in the mental health industry.
  • One of the largest health care fraud suits in US history was in mental health, yet it is the smallest sector within health care.
  • A study of US Medicaid and Medicare insurance fraud, especially in New York, over a twenty-year period, showed psychiatry to have the worst track record of all medical disciplines.
  • To find out more, download this free report from Massive Fraud: Psychiatry’s Corrupt Industry http://www.cchr.org/sites/default/files/CCHR_Pamphlet_Massive_Fraud_1.pdf

The Miami Herald

by Jay Weaver

The first Miami defendant in the nation’s largest mental healthcare fraud case pleaded guilty to paying millions of dollars in kickbacks in exchange for Medicare patients who didn’t need the costly therapy.

Her job as marketing director for a Miami-based mental healthcare chain was to bring in the patients and nobody did their job better than Margarita Acevedo.

Investigators say she paid millions of dollars in kickbacks to South Florida assisted-living facilities, halfway houses and recruiters to supply thousands of Medicare beneficiaries to American Therapeutic Corp.’s chain of seven clinics — patients who didn’t need the costly treatment.

On Thursday, Acevedo, 41, of Southwest Miami-Dade, pleaded guilty to conspiring to pay kickbacks in exchange for patients and conspiring to bilk between $100 million and $200 million from Medicare, in the largest mental healthcare fraud case in the country.

Her change of plea in a Miami federal court makes Acevedo the first defendant among 24 indicted since last fall to admit playing a role in American Therapeutic’s “massive fraud scheme” against the taxpayer-funded healthcare program for seniors and the disabled, according to court records.

She faces between 12 and 15 years in prison at her mid-July sentencing, according to sentencing guidelines.

Prosecutors are expected to recommend a lesser sentence because she is providing the Justice Department with an insider’s view of the alleged racket.

Her attorney, Ira Loewy, declined to comment Friday on her cooperation with authorities.

Acevedo, who joined American Therapeutic in 2005, admitted in a “factual” statement that “in her role as a manager, she worked with the [company] leaders and organizers in recruiting ALF and halfway house owners and supervised co-conspirators in tracking and paying the kickbacks.”

For their part, the residential operators acted as recruiters who took bribes from American Therapeutic’s clinics – $30 for each patient’s daily visit – for supplying thousands of Medicare beneficiaries to keep the racket rolling, authorities say.

American Therapeutic, founded in 2000, allegedly ran its operation for years, tapping into a stream of mentally ill patients who were supposed to have received treatment in local hospitals before qualifying for outpatient group therapy sessions.

Despite conspicuously high claims, the Medicare program never raised an eyebrow. Things began to unravel years later when clinic employees started complaining that many patients were beyond help because they suffered from dementia or Alzheimer’s disease. One employee was fired, leading to a whistle-blower probe of American Therapeutic that became the foundation of the criminal investigation.

Acevedo’s bosses were Lawrence Duran, 48, of North Miami, and Marianella Valera, 39, of Miami, owners of American Therapeutic. They were charged with directing the conspiracy to defraud the Medicare program, leading a network of company employees, psychiatrists and patient recruiters who also face criminal charges.

In March, the couple’s lawyers told U.S. District Judge James Lawrence King that they plan to plead guilty, but they have not done so yet. Their trial is set for August.

Duran and Valera were poised to change their initial not guilty pleas, but a major dispute over how much the couple allegedly bilked from Medicare held up everything. Their lawyers, Lawrence Metsch and Arthur Tifford, have argued that the figure should be $83 million, the actual amount the federal program paid their company since 2003.

Justice Department attorney Jennifer Saulino has argued that the figure should be about $200 million, the amount their company billed Medicare during that period.

The feds have frozen the couple’s personal and corporate bank accounts, Saulino said. They also possess about $7 million in assets, such as luxury cars, real estate and jewelry, that authorities seized with a temporary restraining order.

. Duran, who was born in New York, and Valera, a native of Peru, are being held at the Federal Detention Center in Miami because a judge found both to be a flight risk.

To read more about psychiatric health care fraud


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American Psychiatric Association’s Interests in Conflict

Friday, December 31st, 2010

CounterPunch New Year’s Edition
December 31, 2010 – January 2, 2011

by Martha Rosenberg

At the annual American Psychiatric Association meeting in New Orleans this summer, 200 protestors chanted “no conflicts of interest” and held up photos of individual doctors outside the convention center. Inside the hall, their charges were verified.

The meeting’s Daily Bulletin disclosed that the APA president himself, Alan Schatzberg, has 15 links to drug companies including stock ownership and serving on a speakers bureau.

Doctors on other speaker bureaus like Shire’s Ann Childress and Wyeth’s Claudio Soares gave presentations and workshops that — surprise! — extolled company drugs.

And signing books, side by side, was the duo now accused of penning an entire book for the drug industry: Alan Schatzberg and Charles Nemeroff.

This month ProPublica and the New York Times report that Schatzberg and Nemeroff’s book, Recognition and Treatment of Psychiatric Disorders: A Pharmacology Handbook for Primary Care, may be the first entirely drug industry-approved textbook ever. Published in 1999, the book’s preface says it was funded by an unrestricted education grant to Scientific Therapeutics Information through London-based GlaxoSmithKline (GSK). Scientific Therapeutics Information of Springfield, NJ is the same medical publishing company that spun Vioxx.

Schatzberg was investigated by the Senate in 2008 which found “a lack of consistency” between what he earned from drug companies and what he reported to Stanford where he continues to head the psychiatry department. He owns $6 million of stock in a company he co-founded, Corcept Therapeutics, which sought FDA approval for a psychiatric drug despite Schatzberg’s APA position.

Nemeroff, for his part, left Emory University in disgrace after a 2008 Congressional investigation unearthed $1.2 million in drug industry income, his $9 million NIH grant was terminated (a rare occurrence) and he was banned from further NIH grants for two years. But he resurfaced as head of the psychiatry department at the University of Miami in 2009 after the medical school dean, Pascal Goldschmidt, was assured by crony Thomas Insel, director of the National Institute of Mental Health (NIMH), that Nemeroff could still draw NIH money, according to the Chronicle of Higher Education. It was payback for when Nemeroff got Insel a job, say observers. Nemeroff still sits on NIH scientific panels reviewing others’ grant applications, ensuring further cronyism.

Ghostwriting, of course, solves the “Company-Says-Company’s-Product-Is-Great” problem and increases the chance of a paper’s publication in a journal. It helps “authors”‘ careers and may even spur their individual prescribing habits since studies show doctors prescribe more of a drug they are paid to promote.

But the consumer version, unbranded advertising, is also effective: radio and TV commercials posing as public service announcements that push “awareness” of diseases like ADHD, Irritable Bowel Syndrome (IBS), Restless Legs Syndrome (RLS) or Excessive Sleepiness (ES) and drive worriers to sites where they can self-diagnose with simple quizzes.

Meanwhile, the consumer version of bought doctors is “Astroturf” or patient front groups like the “grassroots” National Alliance on Mental Illness (NAMI), investigated by Congress for drug industry links. These bought patients flash mob the FDA with sob stories when an expensive drug is up for approval and lobby Medicaid to not substitute less expensive drugs, inflating entitlement program and insurance premium costs for industry’s benefit.

In the war against drug industry duplicity, company employees are increasingly reporting misdeeds thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlement sums, in some cases. And last month the Justice Department filed the first criminal, not civil, charges against a the drug industry operative, Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. But as long as politicians like former Louisiana Rep. Billy Tauzin, who headed the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to parlay a career’s worth of knowledge and relationships to sell product, the government is essentially fighting itself.

Read the article here: http://www.counterpunch.org/rosenberg12312010.html

For more information on the APA/Conflicts of Interest see:

CCHR: American Psychiatric Association Called Upon to Cut Drug Company Ties and Put Lives of Children Before Profits http://www.cchrint.org/2010/05/21/apa-leaders-called-upon-to-cut-drug-company-ties-and-put-the-lives-of-children-ahead-of-personal-profits/

CCHR: DSM Panel Members Still Getting Pharma Funds http://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/

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Drug Industry Fraud—The Whistle Has Been Blown, But Where’s the Enforcement?

Tuesday, December 28th, 2010

Counter Punch, December 28, 2010

by Ralph Nadar

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 GlaxoSmithKline 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 can not 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!

http://www.counterpunch.org/nader12282010.html

Ralph Nader is the author of Only the Super-Rich Can Save Us!, a novel.

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Drug Industry Settlements In 2010 Largest Ever—$2.5 Billion

Tuesday, November 23rd, 2010

NPR November 23, 2010

by Carrie Johnson

Image: Carlos Porto

The Justice Department has collected a whopping $3 billion in settlements this year with help from whistleblowers and a powerful law known as the False Claims Act, Assistant Attorney General Tony West announced this morning.

And guess where $2.5 billion of that $3 billion came from? Big Pharma.

This year’s biggest hauls under the False Claims Act include $669 million of the record-shattering $2.3 billion total the government took from Pfizer over its improper promotion of the painkiller Bextra, $302 million from Astra Zeneca over the anti-psychotic drug Seroquel, and $192 million from Novartis.

West told reporters the Civil War era law had become “one of our most successful civil enforcement tools,” allowing the Justice Department to recover “money that otherwise would have padded the bank accounts of defendants who sought profit over quality.”

And he vowed that the Obama administration would do more to go after individual executives who had green-lighted frauds against the federal government by seeking to bring civil and criminal charges that could put them out of business and in some cases, into federal prison.

“We’re going to hold both companies and individuals accountable,” West said.

Justice Department officials say the 2010 health care recovery is the largest in history, and the total recovery is the second largest, up from some $2.4 billion last year. Altogether, they’ve taken in $5.4  billion since January 2009 under the Act.

Congress recently strengthened the law and expanded the ability of whistleblowers to recover money if they alert the Securities and Exchange Commission to financial fraud.

That, West said, could be one of the next fronts in a battle against fraud that’s been intensifying rapidly.

http://www.npr.org/blogs/health/2010/11/22/131517940/drug-industry-settlements-in-2010-largest-ever-under-false-claims-act

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Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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Mental health clinics targeted in Medicare fraud crackdown

Friday, October 22nd, 2010
Agents raid chain of mental health clinics accused of filing false claims

Miami Herald

By Jay Weaver
October 22, 2010

Even by Miami-Dade’s reputation for Medicare fraud, the indictment was a shocker:

American Therapeutic’s patients could not feed themselves or control their own bodily waste.

Many lacked the mental capacity to respond to counseling; instead they simply stared at walls or watched TV.

An employee complained that those patients should be ineligible for Medicare since they could not benefit from treatment.

She got fired.

That launched whistle-blower and criminal investigations that led to the Justice Department’s takedown Thursday of Miami-based American Therapeutic Corp., the nation’s largest chain of mental health clinics.

Federal prosecutors charged the company and four top executives with scheming to fleece $200 million from the taxpayer-funded healthcare program.

“Some of the patients were not even cognizant of where they were or what was going on around them,” said Lanny A. Breuer, assistant attorney general of Justice’s criminal division.

“Other patients were simply there to make money, through kickbacks,” said Breuer, who flew to Miami for a news conference at the U.S. attorney’s office.

At the crack of dawn Thursday, federal agents arrested Lawrence S. Duran, 48, of North Miami, the owner of American Therapeutic; Marianella Valera, 39, the company’s CEO; Margarita Acevedo, 40, the firm’s marketing director; and Judith Negron, 39, vice president of a subsidiary.

Since 2003, Medicare paid the chain a total of $84 million — taxpayer money that authorities say was mostly blown on luxury items, including Duran’s 2009 Maserati Quattroporte and Valera’s bayfront condo at the Opera Towers. Duran and Valera also spent the money on trips to Switzerland, Dominican Republic and Cuba.

The feds obtained court orders to freeze the employees’ personal and corporate bank accounts in an attempt to salvage possibly a few million dollars of the Medicare payments.

The indictment charged American Therapeutic, a seven-clinic chain, and its subsidiary, Medlink Professional Management Group, Inc., and the four employees with conspiring to defraud Medicare for group therapy sessions that were either unnecessary or not provided to patients, many suffering from Alzheimer’s or dementia.

The ring is also accused of paying bribes to recruiters who tapped into an endless supply of patients from assisted-living facilities and halfway houses, who also received kickbacks for the referrals.

The accused ringleaders, Duran and Valera, instructed doctors and employees to alter patient charts, medical diagnoses, therapy session notes and drug medications to make American Therapeutic’s thousands of claims look legitimate to Medicare, according to court documents.

Whether they harmed any patients is the subject of “an ongoing investigation,” Breuer and other Justice Department officials said.

On Thursday morning, 160 agents from the FBI and Health and Human Services raided American Therapeutic’s clinics at 1801 NE Second Ave. and other South Florida locations. They carried out boxes of records, computers and other evidence and loaded them into vans. Patients who showed up for their daily mental health sessions were asked to leave.

IN COURT

Later Thursday, in federal court, the four defendants had their first appearance. They were dressed in Euro-style T-shirts and pants — though they were cuffed at the wrists and ankles.

Jennifer Saulino, a Justice Department attorney, recommended no bond for Duran and Valera and $1 million bail for Negron and Acevedo.

“This was the largest Medicare fraud scheme in this district, and, as you know, Your Honor, that’s saying quite a lot,” she told Magistrate Judge Edwin Torres. “This was a big fraud, and these were big players.”

Acevedo was granted a $350,000 bond. The other three will have pretrial detention hearings on Tuesday.

The scope of South Florida’s alleged $200 million case surpassed that of a vast network of Armenian gangsters and their associates charged last week with operating phantom healthcare clinics to try to cheat the federal program out of $163 million.

U.S. authorities touted that case as “the largest Medicare fraud scheme ever perpetrated by a single criminal enterprise,” with 73 people charged in New York, Los Angeles and other cities.

The Miami indictment signaled the Justice Department’s latest assault against rampant Medicare fraud in South Florida.

U.S. Attorney Wifredo Ferrer called mental health fraud the latest scam in a series involving medical equipment, HIV infusion and home diabetic services.

Authorities said the magnitude of such fraud is eye-opening: More than 100 Florida mental health centers, mostly in Miami-Dade, submitted $425 million in bills to the Medicare program last year.

In turn, Medicare paid $171 million to the Florida clinics, with almost all of that money going to mental health operators — such as American Therapeutic — in Miami-Dade, Broward and Palm Beach counties.

Indeed, reimbursements to South Florida clinics alone accounted for 56 percent of Medicare’s entire payments to mental health centers nationwide last year, according to the agency’s records.

American Therapeutic is not only Medicare’s highest biller of mental health services in the country, but Duran also has been active in a Washington, D.C., lobbying group called The National Association for Behavioral Health.

A video of Duran’s visit in January to the congressional office of U.S. Rep. Ileana Ros-Lehtinen, R-Miami, was posted on You Tube, in which he talked about protecting mental health services under the healthcare reform legislation passed by Congress this year.

Also, Duran and two other South Florida healthcare businessmen were pictured with the congresswoman in a photo posted on the Behavioral Health’s website.

Confronted with an onslaught of suspicious claims, Medicare administrators began placing many suspect Miami-Dade mental health clinics on what is known as “prepayment review.”

That means payments are frozen until Medicare can verify that doctors prescribed the services, the clinics provided the counseling sessions, and patients received and benefited from them.

Without confirmation, the clinics aren’t paid, which has led to some shutting down.

Read the entire article here:  http://www.miamiherald.com/2010/10/22/v-fullstory/1885571/mental-health-clinics-targeted.html

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