Whistleblower Complains of Pfizer Hiding Adverse Events

Pfizer May Be Liable for Firing Whistle-Blower


By WILLIAM DOTINGA

http://www.courthousenews.com/2012/03/02/44377.htm

SAN JOSE, Calif. (CN) - A former Pfizer executive can pursue claims that the pharmaceutical giant fired her for blowing the whistle on "dirty" data, a federal judge ruled Thursday.


Delina Ferretti, who worked for Pfizer as lead clinical protocol manager, worked with a molecule that showed promise as a cancer inhibitor in a project known as PanHER. When she noticed problems with her data, she discovered more than 200 instances of study participants using prohibited medications, as well as instances of adverse events and changes from baseline that went unreported in Pfizer's brochure and report to the Food and Drug Administration, according to her original complaint.

Pfizer "refused to do anything about the 'dirty' study results," Ferretti's suit claims.

The company allegedly reacted to her report of the trial defects by creating a hostile work environment that made Ferretti feel "vilified and disregarded." Ferretti says she was alternately "shut out" of meetings or forced to meetings necessary preparation time.

Though Pfizer let Ferretti transfer out of the PanHER program, it further subjected her to a hostile work environment, the complaint states. In March 2010, she reported her concerns about study safety, unreported adverse events and the hostile work environment to Pfizer's compliance hotline. After responding to and refuting two performance improvement plans, Ferretti learned she would be terminated in August 2010.

Ferretti filed suit the following year, but U.S. District Judge Lucy Koh severed her retaliation claim Wednesday, finding that it should have first gone to the labor commissioner.

Ferretti's wrongful termination action does not need to meet that requirement, however. "Unlike a statutory retaliation claim under [labor code], a common law wrongful termination in violation of public policy is not subject to the exhaustion requirement," Koh wrote.

Under California's labor code, an employer may not retaliate against an employee for refusing to participate in activities that violate state or federal law. Pfizer argued that Ferretti's refusal to participate in its alleged defective testing does not constitute protected activity.

Koh disagreed. "Even assuming that none of plaintiff's 'protected disclosures' exceeded the bounds of her official duties, plaintiff alleges that she not only made 'protected disclosures, but that she also refused to participate in illegal activity," the decision states.

The ruling notes Ferretti's claim that she refused to participate in PanHER because it violated five federal regulations for Investigational New Drugs (IND).

"Thus, taking all the facts in the light most favorable to plaintiff, as the court must on a motion to dismiss, it is reasonable to infer that plaintiff refused to participate in defendant's PanHER program because defendant's PanHER program violated and would continue to violate several federal IND regulations," Koh wrote.

"'Refusing to participate in an activity that would result in a ... violation or noncompliance with a ... federal rule or regulation' is explicitly protected under California Labor Code," Koh wrote, adding that the alleged activity is thus protected.

Koh also disagreed that Ferretti's activities were within the scope of her employment duties, and therefore not protected.

"A jury could construe her refusal to 'accede to an alleged practice' of not complying with and masking violations of IND regulations by requesting to be transferred out of the program 'as a position adverse to [defendant],'" Koh wrote, citing 2010 precedent.

Ferretti has also properly alleged that the company knew why she requested a transfer out of PanHER, the decision states.

"Thus, taking the facts in the light most favorable to plaintiff, plaintiff has alleged sufficient facts to draw the reasonable inference that defendant had either actual or constructive notice that plaintiff requested to be transferred because she refused to participate in illegal activity when defendant terminated her in September 2010," Koh ruled.

Ferretti's claim of wrongful termination regarding unsafe working conditions cannot proceed, however, as she did not demonstrate that she reported such conditions.

Koh also rejected Ferretti's claim of intentional infliction of emotional distress. "Indeed, besides alleging that she had 'concerns,' plaintiff has not alleged any facts to support her conclusory allegation that she suffered 'severe emotional distress,'" Koh concluded (italics in ruling).

Ferretti can seek attorneys' fees and file an amended complaint within 21 days to address the granted motions, Koh sa

Pfizer Groton Occupied

Video from Occupy Shoreline CT.org 
http://occupyshorelinect.org/content/f29-pfizer-alec-protest-groton-ct#comments

Close to one hundred people in Connecticut gathered on March 29, 2012 to protest Pfizer in front of their large facility in Groton, Connecticut.  Pfizer, the largest pharmaceutical company in the world, is a member of a controversial group called the American Legislative Exchange Council (ALEC).  ALEC aligns with government and legislators to make laws that unfairly favor corporations over working people. 

This protest at Pfizer Groton was one of many protests all over the nation against Pfizer by Occupy Wallstreet groups.  Pfizer which made more than $68 billion in business last year was recently cited for a $2.3 billion settlement  for repeat offenses of illegal off-label marketing of their drugs to make extra profits.  Under a federal law, Pfizer was supposed to be excluded from selling drugs within Medicare because of their serious repeated criminal acts of fraud.  Pfizer, however, was later classified as "too big to nail" and was not penalized allowing them to participate within Medicare without restrictions.

While Pfizer was not prosecuted to the fullest extent for crossing the line of legal and ethical standards, eight people during the protest were alleged to have crossed Pfizer-police lines and were arrested at Groton Pfizer.  They were cited for first degree criminal trespass.  These eight people, acting on behalf of the 99%, were Alex Suarez, Danielle Digirolamo, Ashley Gillece, Cassandra Johnson, James Crombie, Joshua Heltke, Gregory Walker and Erin Mitchell.  Unlike Pfizer which is "too big to nail", these citizens were apparently "too small and got nailed".

People around the nation continue to protest against corporations like Pfizer and members of ALEC.  These bad corporate actors take actions and make laws that are not on the working people's side.

Other links:
http://www.theday.com/article/20120301/NWS01/303019537/1017

Video from Occupy Shoreline CT.org

http://occupyshorelinect.org/content/f29-pfizer-alec-protest-groton-ct#comments

Scientific Misconduct in Cancer Research_Duke University, Yale University, NIH & FDA

Researchers rush to make money off biotechnology & kill patient
An article by the New York Times tells a story of a combination of bad science and scientific misconduct involving Duke University, Yale University, FDA and NIH resulting in the death of a cancer patient.  See story:  http://www.nytimes.com/2011/07/08/health/research/08genes.html?_r=1&hp

The Reasons NOT to Invest in Pfizer Keep Rolling In!

U.S. Joins Pfizer Suit Over Drug’s Marketing

By DUFF WILSON

NY Times
Published: September 21, 2010

The Justice Department on Tuesday joined a whistle-blower lawsuitagainst Pfizer and its subsidiary Wyeth Pharmaceuticals that accuses Wyeth of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants.
Reuben A. Guttman, lawyer for two former Wyeth employees, predicted that the government action could result in recovery of hundreds of millions of dollars in inappropriate billings to public health programs. Nineteen states, including New York, and the District of Columbia also joined the filing.


“It’s always good to have the government on your side,” Mr. Guttman said.

Ray Kerins, a Pfizer spokesman, said the company had previously disclosed that it was cooperating with a government review of Wyeth’s promotional practices involving Rapamune. Pfizer also disclosed in February that there was a criminal investigation into the marketing.

In a statement, the company said the whistle-blower suit was filed in 2005, four years before Pfizer bought Wyeth for $68 billion. Pfizer could be in violation of a corporate integrity agreement it signed a year ago in a separate case if it was involved in further illegal sales.

In that case, Pfizer paid $2.3 billion, including a $1.3 billion criminal fine, the largest in United States history, to settle investigations into illegal marketing of the painkillers Bextraand Lyrica, the schizophrenia drug Geodon and the antibiotic Zyvox.

Patrick Burns, a spokesman for Taxpayers Against Fraud, a Washington nonprofit group that works with many whistle-blowers under the federal False Claims Act, said the government nearly always wins when it joins such a legal action.

“It’s going to be a big case,” Mr. Burns said. “The wild card is, it’s Pfizer. The government’s not happy with Pfizer. These are repeat offenders.”

Charles S. Miller, a spokesman for the Justice Department, declined to comment, saying the brief government filing spoke for itself. Such cases are typically shrouded in confidentiality.

The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit ofForest Laboratories for $313 million.

Rapamune had sales of $376 million in 2008. The law allows the government to collect up to three times any amount it was defrauded and pay whistle-blowers 15 to 25 percent of the total. Mr. Guttman said most of those sales were for uses not approved by the Food and Drug Administration.

While doctors can use an approved drug for anything they see fit, companies are prohibited from marketing drugs for uses not approved by the F.D.A.

In the whistle-blower suit, filed in United States District Court in Philadelphia, the former employees, Marlene Sandler and Scott Paris, said they were encouraged to promote the drug for heart, lung, liver and pancreas transplants, even though the F.D.A. had only approved it, in 1999, for kidney transplants.

The suit also contends that Wyeth singled out two hospitals with largely black clients for off-label promotions. They were the SUNY Downstate Medical Center in New York and theAlbert Einstein Medical Center in Philadelphia. Black patients have higher risk oftransplant rejection. The Pfizer statement on Tuesday said that Wyeth was allowed to market Rapamune for that population.

The Justice Department during the Bush administration declined to join in the Rapamune case. Mr. Guttman praised the Obama administration for aggressive action.

Mr. Burns said the civil division of the Justice Department, which handles the cases, has been nonpolitical and commonly joins an action, after first declining, once new information emerges. He also said the health care reform overhaul strengthened the False Claims Act and increased money for enforcement.

http://www.nytimes.com/2010/09/22/business/22drug.html?_r=1&scp=1&sq=U.s.%20Joins%20Pfizer&st=Search

Dr. Woo, Gene Therapy and Scientific Misconduct

Why do scientists cheat?

Two unidentified post-docs from Mount Sinai School of Medicine have been terminated due to an investigation of scientific misconduct regarding falsification of data in three renown scientific journals related to gene therapy.

The work came from the research lab of Savio Woo, a leading gene therapy scientist studying phenylketonuria.

Gene therapy is an advanced biotechnology that uses genetically engineered infectious agents to target cures for human genetic diseases. Gene therapy is controversial because it has caused the deaths of patients in the past.

Despite the embarrassment, it is of value that Mount Sinai has taken disciplinary action against these scientists. It would be beneficial, however, to hear the other side of the story, making sure that these scientists have not been falsely accused. It also would be beneficial to address the reason why this scientific misconduct was not discovered earlier. 

Falsifying data has happened in the past in the scientific world.  It does, however, seem suspicious that TWO scientists would collude to falsify data.

http://topnews.com.sg/content/24918-researchers-dismissed-following-scientific-misconduct-gene-therapy-lab

http://retractionwatch.wordpress.com/2010/09/23/gene-therapy-researcher-savio-woo-retracts-two-more-papers/

http://retractionwatch.wordpress.com/2010/09/15/work-from-noted-gene-therapy-research-under-scrutiny-with-slew-of-retractions/

US Pharmaceutical Companies Under Scrutiny for International Bribery

US probes corruption in big pharma

Financial Times
By Stephanie Kirchgaessner
August 12, 2010

The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.

GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.

An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.

The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.

The investigation is at a relatively early stage but is considered a priority for the DoJ.

While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.

The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.

That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery ­investigation.

GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.

Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.

There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.

Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.

“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.

According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.

Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrong­doing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.

Read entire article here: http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html

Columbia University Caught Doing Unethical Clinical Medicine

For four years Columbia University has knowingly performed unethical and dangerous human clinical research on patients at their PET (positron emission tomography) imaging research facility in New York, where they injected contaminated drugs into human subjects for brain research studies.

Despite the fact that Columbia University scientists knowingly performed unethical research and even falsified documents trying to hide their wrong-doing, the FDA fortunately recently caught them…red handed.

And even more fortunately, the New York Times found out about it six months later, publishing an article entitled, “Studies Halted at Brain Lab Over Impure Injections”.

What are the ramifications to Columbia University for knowingly performing four years of unsafe research on human subjects?

Not much. The only notable change was that top level scientists involved in this debacle got re-assigned….not terminated…no jail time…just reassigned. Woweeee. That is really a hardship.

Hmmmm. And we wonder why these types of unethical practices are common place and condoned in the ivory towers of the academic community?

Columbia University is not above controversy. For example, to get a competitive lead on human embryo research, they have instituted unethical practices of paying women for egg donation. Egg donation is not a procedure without serious risks, risks that many women are really not aware and risks that unfortunately have caused harmed. Again…more unethical practices and disregard for human rights and human dignity.

Columbia University receives millions of dollars of public funding to carry on their research. Columbia University also receives million of dollars from pharmaceutical companies to do their bidding on drug testing too, which coincidently, was part of this four year unethical brain research debacle mentioned above. These types of pharmaceutically-funded research arrangements, unfortunately, often cause conflicts of interests where public health and safety is left behind for commercialization and money-driven incentives.

The public is becoming more and more aware that academic institutions have too strong of monetary ties with industry which thwarts public health and safety advocacy.

And the public is beginning to question why we keep giving public funds to institutions that show blatant disregard for public health and safety, that being involved with either clinical research practices, worker safety, injured workers or human rights issues.

The public is in desperate need for research institutions that will serve public health and safety and advocate for public rights.

Perhaps it is time to rethink public funding to academic institutions that do not advocate for the public.

Scientific Misconduct at Mayo Clinic

Since 2002 several published scientific papers regarding dendritic cells from the Mayo Clinic have been published with promising hope for anti-cancer treatments. This year, however, dozens of those papers had to be retracted due to fraudulent scientific studies. Even more, a clinical trial in attempts to commercialize on these published discoveries had to be discontinued.

The scientific misconduct occurred in Dr. Larry Pease's lab where molecular immunology research was performed. It has been alleged that a scientist, Dr. Suresh Radhakrishnan in Pease's lab has falsified data. Dr. Radhakrishnan denies any wrong doing.

The question remains, however, how can 8 years of continuous research go forward without finding the falsified data and the problem sooner?

More details are needed regarding getting to the facts of this story to really find out what has happened.

Here are links to some details:
http://blogs.nature.com/news/thegreatbeyond/2010/05/promising_therapy_scuttled_by.html
http://scienceblogs.com/drugmonkey/2010/05/eight_retractionsso_far.php
http://www.the-scientist.com/blog/display/57449/

Problems with American Science?

Is the way America manages science going in the wrong direction?

J. Marvin Herdon thinks so and provides what he believes are problems in the scientific system and some solutions. Below is an excerpt from an article by him entitled "J. Marvin Herndon's American Science Decline: the Cause and Cure.

"Science is an important component for the strength of America and for the well being of her people. Science is the mother that gives birth to the technology that makes our economy robust and our military strong. Science improves our health and enables us to see our world in ways never before envisioned, uplifting spirits and boosting national prestige. But for the past four decades, despite ever-increasing science budgets, American science has continued to decline toward third-world status. Why? Because fundamental mistakes underlie the methodology by which the U.S. Government supports science.

Before World War II there was very little government funding of science, but that changed because of war-time necessities. In 1951, the U.S. National Science Foundation (NSF) was established to provide support for post-World War II scientific research. The methodology for administrating science-funding, invented in the early 1950s by NSF, has been adopted essentially unchanged by virtually all subsequent U.S. Government funding agencies, such as the National Aeronautics and Space Administration (NASA) and the U.S. Department of Energy (DOE). The problem is this: That methodology is flawed and those flaws have been gradually undermining, corrupting, and trivializing American science for decades. Here I disclose the principal flaws and point the way for the President of the United States to correct them."

For the entire article click this link: http://www.nuclearplanet.com/Anerican%20Science%20Decline.html

Pfizer Continued Unethical Business Practices, Continue to Make the Bucks

Martha Rosenberg writes an article which provides a summary of how Pfizer is banking the bucks with their continued unethical business practices, with their involvement in questionable practices with government agencies and how it causes serious health harm to the public consumer.

An interesting point in the article is made when it hypothesizes that the government can't get tough on Pfizer by preventing Pfizer to sell drugs to Medicare, Medicaid and VA. "The government is not really in a position to be cutting itself off from all that medicine."

Why not? Why can't unethical companies loose patent rights when they use unethical business practices? Why not let a different, but ethical company make the same drugs and sell them to Medicare, Medicaid and the VA?

Although the article is good, Rosenberg forgets to mention, however, that after Pfizer was fined 2.3 Billion dollars for unethical business practices by the US government, Pfizer CEO Jeffry Kindler was appointed to the Federal Reserve Bank of New York. The Federal Reserve is one of the single most influential bodies for setting US monetary standards and policy in the United States. Hello...anyone home?

Rosenberg's article is below:

Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You
By Martha Rosenberg, AlterNet Posted on July 10, 2010, http://www.alternet.org/story/147467/

Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You
By Martha Rosenberg, AlterNetPosted on July 10, 2010, Printed on July 12, 2010http://www.alternet.org/story/147467/
The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

But the "world's largest research-based pharmaceutical company" which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

To say Pfizer's been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson's disease, kidney transplants and leukemia.

For more go to this LINK: http://www.alternet.org/story/147467/

Supreme Court UPHOLDS International Right to Sue Pfizer in U.S. Courts

The U.S. Supreme Court yesterday upheld an appeals court decision to allow Nigerian families to sue Pfizer in U.S. courts due to international law violations. Pfizer conducted unethical clinical trials on Nigerian children using a drug called Trovan in 1996 resulting in deaths of 11 children and leaving many other children blind, deaf, paralyzed or brain damaged. Whistleblower and medical doctor, Dr. Juan Walterspiel warned top level Pfizer management regarding the unethical trial, but Pfizer proceeded anyway, terminating Walterspiel. The case is Pfizer vs. Abdullahi, 09-34. For more see this article: http://online.wsj.com/article/SB10001424052748704103904575336750320252326.html?mod=googlenews_wsj

FIRM questions Pfizer's Misconduct

See the post below written by Dr. Roy M. Poses, MD who is President of the Foundation for Integrity and Responsibility in Medicine (FIRM) regarding the business ethics of Pfizer. Poses raises the question of why corporate misconduct is not being addressed appropriately.

http://hcrenewal.blogspot.com/2010/04/pfizer-settles-one-lawsuit-loses.html

Also see link to FIRM's website, an educational non-profit which supports physician core values and advocates ethical health care governance: http://www.firmfound.org/

Corporate Criminals Not Prosecuted

Coddling Pfizer
Praise the Criminal, Dis the Whistleblower
By CORPORATE CRIME REPORTER
Pfizer's Pharmacia & Upjohn Company Inc. unit pled guilty yesterday to offering a kickback in connection with the sale of its human growth hormone product.
The Wall Street Journal, New York Times, and Washington Post ignored the story.
Why is unclear.
The settlement was a complicated one, negotiated by Jeremy Sternberg and Susan Winkler of the U.S. Attorney's office in Boston and by Pfizer attorney Ethan Posner.
Posner is a partner at Covington & Burling in Washington, D.C.
Posner did not return calls seeking comment for this story.
A second Pfizer unit, Pharmacia & Upjohn Company LLC, entered into a deferred prosecution agreement for illegally promoting its human growth hormone drug Genotropin for such off-label uses as anti-aging, cosmetic use and athletic enhancement.
The companies will pay a total of $34.7 million in fines and penalties.
As a result of the plea agreement and the deferred prosecution agreement, Pfizer Inc. was granted a non-prosecution agreement.
Nice deal, if you can negotiate it.
U.S. Attorney Michael Sullivan said Pfizer "acted responsibly" for voluntarily and fully self-disclosed the off-label promotion of Genotropin.
This ticked off Peter Rost.
Rost was a vice president at Pfizer when he discovered the criminality and blew the whistle.
Rost has two lawsuits pending against Pfizer.
One lawsuit accuses Pfizer of violating the False Claims Act. That lawsuit is pending on appeal to the First Circuit Court of Appeals in Boston.
The other--for wrongful dismissal--is in discovery.
How come the Justice Department is praising Pfizer and not Rost?
"The Justice Department praised Pfizer for self-reporting," Rost told Corporate Crime Reporter. "But Pfizer would have done nothing if I didn't twist its arm. I was floored when I read the press release. They have one guy who lost his career, lost his job for doing the right thing. That would be me. And they praised the company that fired me?"
In fact, the U.S. Attorney's criminal investigation was triggered by the filing of Rost's False Claims Act case.
Rost documents the history of the case in his book--The Whistleblower: Confessions of a Healthcare Hitman.
And Rost testified twice before the federal grand jury in Boston that investigated the Pfizer criminal wrongdoing.
And yet the federal government refused to join Rost in his False Claims Act case.
Why?
"Not only didn't they join in the False Claims Act case, they didn't even say thank you," Rost said. "They praised Pfizer, but not me. Instead, in the press release they negotiated with Pfizer, they state that 'Pfizer acted responsibly when it self-disclosed to various federal government agencies in May 2003.' There's not a word about the whistleblower that Pfizer fired, or that the whistleblower fought since October 2002, trying to get the company to rectify and disclose the problems."
Rost said his lawyers will seek to open negotiations with prosecutors in Boston this week to reach a settlement.
The Pfizer unit that pled guilty will pay a criminal fine of $19.98 million.
And federal prosecutors boasted that this company will be "excluded permanently from participation in all federal health care programs."
Translated--the unit that pled guilty is an empty closet somewhere inside the Pfizer beast--there is probably nothing to exclude.
Federal officials alleged that Pharmacia violated the federal anti-kickback law by offering to make $12.3 million in excess payments on a distribution to a pharmacy benefit manager in the expectation of obtaining improved positioning for its drug products.
Federal officials alleged that the other unit--Pharmacia & Upjohn LLC--illegally promoted and distributed Genotropin.Genotropin was approved by the Food and Drug Administration solely for the treatment children with growth related diseases.
Instead, Pharmacia engaged in the unlawful promotion of the drug for uses not approved by the FDA such as anti-aging, cosmetic use and athletic performance enhancement.
This unit--the LLC unit--probably has something to lose. That's why it wasn't forced to plead guilty. Instead, it was granted a deferred prosecution agreement.
Under the deferred prosecution agreement--which lasts for 36 months--the company will pay $15 million and cooperate with ongoing growth hormone investigations.
Corporate Crime Reporter is located in Washington, DC. They can be reached through their website.

Link: Published April 3, 2007 Counter punch

Frankenstein, Pharma and Public Health and Safety

Stewart Lyman writes a great article entitled: “Hollywood Sees Corruption in Pharma, and Suddenly Scientists are the Bad Guys.” He outlines some of the egregious behavior from pharmaceutical companies whose power and wealth have allowed a laxity toward public health and safety…all in the name of greed. Lyman talks about Hollywood’s role in demonizing science.

But Hollywood has it right in trying to convey some of these concepts that Mr. Lyman talks about through cinematography. It is important that Hollywood stay the course, too.

Science is now so tied into big money that corruption and loss of public health and safety rights are inevitable, not only from the egregious behavior from powerful Pharma, but also from the academic world who froth over patent rights and who has become monetarily entrenched with big Pharma. Together, pharma and academia, make one powerful network of scientific machinery that is able to manipulate media, government and legislation to their favor without due consideration of public rights and public health and safety.

Unfortunately there is little funding for public advocacy groups to protect public health and safety. So to some extent the public needs Hollywood to continue to tell stories which help educate us about these issues, issues that are subject to human rights and public health and safety abuses.

Even old movies are helpful. With human cloning now a scientific possibility, Hollywood’s portrayal of the human rights issues in the movie, Frankenstein, are issues the public should try to grasp.

Here is the link to Lyman’s article: http://www.xconomy.com/seattle/2009/12/07/hollywood-sees-corruption-in-pharma-and-suddenly-scientists-are-the-bad-guys

PFIZER PAYS 430 MILLION IN CRIMINAL FINES

Pfizer Broke the Law by Promoting Drugs for Unapproved Uses

BY DAVID EVANS Nov. 9 (Bloomberg) --

Prosecutor Michael Loucks remembers clearly when lawyers for Pfizer Inc., the world’s largest drug company, looked across the table and promised it wouldn’t break the law again.
It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.
In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.
New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.
What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off-label marketing even before the ink was dry on their plea.
On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.

For more on this interesting story with many details......go to this link:

http://bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10#

AMGEN IN TROUBLE WITH DRUG KICKBACK SCHEME

States Sue Amgen Over Alleged Kickbacks Plan

By CHAD BRAY
NEW YORK—New York, 13 other states and the District of Columbia sued Amgen Inc. and other drug suppliers over an alleged kickback scheme designed to boost sales of the anemia drug Aranesp, New York Attorney General Andrew Cuomo said Friday.
Mr. Cuomo said in a statement the multistate intervenor lawsuit filed in U.S. District Court in Boston alleges that Amgen, AmerisourceBergen Corp., and AmerisourceBergen's drug wholesaler, ASD Healthcare, and specialty group purchasing unit International Nephrology Network encouraged doctors to bill third-party payers, such as Medicaid, for free samples of Aranesp.
David Polk, an Amgen spokesman, said in a statement, "We believe that the allegations are without merit, and we look forward to the opportunity to examine these matters with the states before the court."
Mr. Cuomo said the lawsuit alleges that Amgen conspired with INN and ASD Healthcare to offer improper kickbacks to medical providers—such as sham consultancy agreements, weekend retreats or other services—to induce them to purchase and prescribe Aranesp.
"Drugs should be prescribed to patients on the basis of need, effectiveness, and safety, not on a corporate giant's promise of an all-expense paid vacation," Mr. Cuomo said. "In an egregious violation of the law, Amgen allegedly bribed medical providers and left taxpayers footing the bill for free drug samples."
The lawsuit was filed in connection with a whistleblower complaint first brought in U.S. District Court in Boston in 2006 against Amgen and others for allegedly illegal marketing of Aranesp. The whistleblower complaint was brought on behalf of the U.S. government and a number of states, including New York.
Amgen's Mr. Polk said the company has a solid compliance program and a code of conduct called "Do The Right Thing." The company expects all employees to follow it at all times, he said.
Michael Kilpatric, an AmerisourceBergen spokesman, said in a statement, "We've had no contact in this case with anyone in the N.Y. AG's office or any other state attorneys general offices and we expect to defend ourselves vigorously. We have received a subpoena from the Department of Justice related to the issues that are set forth in this case and we have been cooperating fully with the Department of Justice, and DOJ has not intervened in this case to date."
The states which brought the suit Friday are California, Delaware, the District of Columbia, Florida, Hawaii, Illinois, Indiana, Louisiana, the Commonwealth of Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, and the Commonwealth of Virginia.
Write to Chad Bray at chad.bray@dowjones.com

REFERENCE LINK: http://online.wsj.com/article/SB10001424052748703399204574505742295659108.html

Scientific Misconduct and Lab Safety at Harvard

First we find a Yale scientifist buried in the walls of an animal facility and now we discover tainted coffee at Harvard leaving six medical researchers poisoned. Lab safety gone bad.

See story: Harvard: Lab workers poisoned by tainted coffee

Pfizer's Continued Bad Conduct Incites ACORN Act

Minnesota Democrat Betty McCollum, a member of the House Appropriations Committee appears to be tired of the hypocrisy of the federal government of allowing corporate felons, like Pfizer to continue to win massive government contracts.

McCollum is found saying, “It’s time Congress get serious about taxpayer funding of corporate cheats, crooks and criminals.”

Her position came after Pfizer had to pay $2.3 billion settlement with the Justice Department after Pfizer defrauded government health care programs and paid kickbacks to health care providers, inducing them to prescribe their off-labeled marketed drugs. All of this fraud cost the American taxpayers billions of dollars.

Apparently Pfizer is a habitual violator. They have intentionally violated the law over an extensive period of time and even continued to do so when settling prior cases with the government. As quoted by attorney general Tony West, Pfizer’s behavior “puts the public health at risk”, corrupts medical decisions by healthcare providers and costs the government billions of dollars.”

Despite Pfizer’s historical bad conduct, they continue to win massive government contracts. McCollum is mad as hell.

McCollum wants to place penalties onto corporate cheats like Pfizer by inhibiting their ability to obtain federal contracts, grants or any other form of benefit for a 5 year period beginning 30 days after the date of the criminal conviction. McCollum also wants to stop corporate cheats from contributing to campaign politicians for 5 years which will limit their political prowess. She is introducing her bill entitled, “Against Corporations Organizing to Rip-off the Nation Act of 2009” which ironically is abbreviated as ACORN Act.

I think McCollum is on to something here. Her bill won’t throw the criminals in jail (where actually they belong), but it will somewhat limit their political power for at least 5 years. It is a step in the right direction to dissuade big wealthy corporations from their continued unethical business practices which harm the American people, cost us billions of dollars and harm the integrity of the American system.

For more on this topic, see an excellent article by Jeremy Scahill, published in The Nation on Oct 5, 2009, entitled, “An ACORN Amendment for Pfizer.”

After 10 years Gene Therapy Death Still a Secret

Jesse Gelsinger: Ten Years Later

Posted by Osagie Obasogie from Genetics and Society on September 25th, 2009

Last Thursday marked the ten-year anniversary of Jesse Gelsinger’s death. The 18-year-old died while participating in a gene therapy clinical trial at the University of Pennsylvania. News of his death in September 1999 and the shady circumstances surrounding it rocked the medical research world. These circumstances included a failure to disclose the deaths of monkeys in pre-clinical trials, adverse reactions among humans in prior tests, and financial ties between a researcher and a private biotech company, in which the main investigator stood to make millions if the trial was successful. In the wake of this tragedy, investigative journalists and federal hearings dug up mounds of evidence concerning the inadequacy of human research protections and, in particular, the many failings that led to Jesse’s death. While some of the findings from the federal investigation were made public, several key documents remain hidden from public view to this very day. Last week in a Philadelphia Inquirer op-ed, Jesse’s father renewed his plea for their release:
I thought the lawsuits brought by me and the government would change research practices and the rules governing research. When I settled, real reform seemed likely. The Senate had held hearings, the FDA was investigating whether mistakes were made in the trial, and influential medical bodies such as the Association of American Medical Colleges had begun to examine disclosure practices and financial ties.But, sadly, we have not yet learned enough from Jesse's death. The shroud of secrecy that envelops legal settlements has helped hinder reform. No one has publicly accounted for the mistakes that led to Jesse's death.We don't know whether the FDA was misled or dropped the ball. We don't know whether the researchers' claims of efficacy had any basis in fact or were just wishful thinking. We don't know why Penn approved the deal despite warnings. And we don't know whether the researchers' decision to administer the virus to Jesse was reasonable or reckless.Ten years ago today, my son died in a science experiment. A complete record of what the researchers and FDA regulators knew is the best precaution against future tragedies like Jesse's death.I am asking that the University of Pennsylvania and the FDA finally do the right thing and release their records. If they did nothing wrong, let us see the proof. If they made a mistake, let us all learn from it and do better in the future. We owe it to Jesse to make his life and death mean something.

Pfizer Pays $2.3 Billion for Being a REPEATING CORPORATE CHEAT

WASHINGTON (AP) — Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs. "There's so much money in selling pills, that there's a tremendous temptation to cheat," said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports. "There's a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat.

This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship."

Excerpts above taken from "Repeat offender Pfizer paying record $2.3B settlement for illegal drug promotions" by Devlin Barrett. For complete article click HERE.

See also: http://www.courant.com/business/sns-ap-us-pfizer-settlement,0,3526777.story