Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

Friday, November 16, 2018

Former Pfizer Executive Of HHS Beats Himself To Death

I just found it quite odd that one would choose his method of suicide to be beating himself up with a blunt object with the medical examiner concurring.

He was an executive at Pfzier.

But, hey, what do I know? 

I know HHS should be in shambles, due to all the Medicaid Fraud in Child Welfare.

Wikileaks Exposes Drugging Kids as Lab Rats

Death of HHS official Daniel Best is ruled a suicide


Daniel Best, a pharmaceutical executive from Bay Village who was tapped to oversee government efforts to reduce prescription drug costs, died on Nov. 1.
Daniel Best was an executive at Pfizer
WASHINGTON, D.C. - The Nov. 1 death of Daniel Best, a pharmaceutical executive from Bay Village who led U.S. Department of Health and Human Services efforts to lower prescription drug prices, has been ruled a suicide, officials in Washington, D.C., said Thursday.

Police say Best was found "unresponsive" near the garage door exit of an apartment building in Washington, D.C.'s Navy Yard neighborhood at 5:25 a.m. on Nov. 1, and was pronounced dead by medical personnel who responded to the scene.

The city's Office of the Chief Medical Examiner on Thursday said Best died from "multiple blunt force injuries" and it ruled his death a suicide. It would not release further information.

In announcing his death, HHS Secretary Alex Azar said the 49-year-old former CVSHealth and Pfizer Pharmaceuticals executive agreed to work at HHS "out of a desire to serve the American people by making health care more affordable."

"He brought his deep expertise and passion to this task with great humility and collegiality," Azar's statement said. "All of us who served with Dan at HHS and in the administration mourn his passing and extend our thoughts and prayers to his wife Lisa and the entire Best family at this difficult time."

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Sunday, February 27, 2011

Wikileaks Exposes Drugging Kids as Lab Rats

Do not believe for one moment the practice of using people under the care of the state and the poor for clinical drug trials has ended, nor should you believe people no longer cover up such practices.

AP IMPACT: Ugly US medical experiments uncovered

ATLANTA -- Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Such experiments included giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland, and injecting cancer cells into chronically ill people at a New York hospital.
Much of this horrific history is 40 to 80 years old, but it is the backdrop for a meeting in Washington this week by a presidential bioethics commission. The meeting was triggered by the government's apology last fall for federal doctors infecting prisoners and mental patients in Guatemala with syphilis 65 years ago.
U.S. officials also acknowledged there had been dozens of similar experiments in the United States - studies that often involved making healthy people sick.  Read more


In child welfare, under the guise of the "best interests of the child" principle, secrecy laws prevent exposing the use of poor and foster children as lab rats.




Uganda's poor children
Children of third world countries and nations in transition have become 'laboratory rats' for the US' clinical tests for new drugs, an Indian newspaper says.


Under US' 1997 legislation called the Pediatric Exclusivity Provision, intended to speed up development of new drugs for American kids, the trials were carried out in countries such as Uganda and India, The Times of India reported.

Although the trials were carried out in such countries, using their children as laboratory rats, it is not clear if okayed medicines might ever become available there and whether they will be affordable for them.

The most egregious activity of using vulnerable poor children as lab rats is the generation of imperialistic morality propaganda to defend the practices of big pharma.


One of the biggest protectors of the practice of using foster kids as lab rats is the law.  The next level of protection comes from media personalities who wanted to persecute the persons who brought this to light.


Glenn Beck covering up
using poor kids as lab rats
"America has suffered an embarrassing leak of classified information via WikiLeaks. According to some reports today, this is the largest loss of sensitive information by a world superpower in all of human history. But the question is, what did we learn from these? Is there anything new here? I've seen much of what it out there and I've heard the people on TV talk about it. This is merely serving to tell you what you already knew – the government is lying to you."

The only way the Department of Justice can approach the issue of stopping the practices of using poor children as lab rats is to engage in unconventional methods.  The Wikileaks or Cablegate scandal allowed for prosecution of health care fraud.  It is not much, but it is a start.
U.S. Embassy Cable on Pfizer Clinical Trials on Children, Their Murders and Settlement


Thursday, February 3, 2011

Pfizer and DOJ Play The $142.1 Million RICO Game For Drugging Kids With Neurontin,

Those wacky pharmaceutical executives over at Pfizer and the Department of Justice are up to their tomfooleries again.

See, the feds take Pfizer to court for breaking their promises of not doping up kids for Medicaid dollars.  The feds bust them and go through a big pie throwing fight in the courtroom.  Pfizer, in the end gets to pay a few pennies as a slap on the wrist, raises its prices for other drugs, bills Medicaid and everyone has a grand old time.  The feds on the case get to put another notch on their belts and everything goes back to normal.


Pfizer to Pay $142.1 Million Over Neurontin Marketing


Pfizer Ordered to Pay $142.1 Million Over Neurontin
Pfizer Inc. was ordered to pay a total of $142.1 million in damages for violating U.S. racketeering laws in the marketing its epilepsy drug Neurontin. Source: Pfizer Inc./ via Bloomberg
Jan. 28 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, was ordered to pay a total of $142.1 million in damages for violating U.S. racketeering laws in the marketing of its epilepsy drug Neurontin.
U.S. District Judge Patti Saris in Boston yesterday upheld a jury's finding that Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals deserved the award over the companies' claims that Pfizer illegally promoted Neurontin for unapproved uses. Saris tripled the jury's award of $47.3 million under a provision of the Racketeer Influenced and Corrupt Organizations Act of 1970.

"The damages awarded to the plaintiffs by the jury under RICO are trebled," the judge said in her one-page order. Saris also denied Kaiser's request for an estimated $76 million in interest on the award.
Kaiser officials alleged they were duped into believing that migraines and bipolar disorder could be treated effectively with Neurontin, approved in 1993 by the U.S. Food and Drug Administration for epilepsy.

Chris Loder, a Pfizer spokesman, said the company was pleased with Saris' decision to deny Kaiser's bid for pre- judgment interest on the award. "As we maintained all along, Pfizer has strong defenses in this case and intends to appeal," he said.
Oakland, California-based Kaiser, the first insurer to bring a Neurontin case against Pfizer to trial, claimed it was forced to pay $90 million more than it should have for the drug.

300 Suits
New York-based Pfizer currently faces more than 300 suits accusing it of illegally promoting Neurontin or hiding its health risks. Lawyers for ex-Neurontin users contend the drugmaker knew the medicine posed a suicide risk and failed to disclose it to patients and doctors.

The company also has settled at least two suits alleging the drug played a role in users' suicides, paying almost $400,000 in one of the accords, people familiar with the deals said last year.

Warner-Lambert Co. developed and marketed Neurontin for several years before Pfizer acquired the drugmaker in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the U.S. Justice Department.

Saris, who is overseeing Neurontin cases from across the U.S. consolidated in federal court in Boston, recently dismissed more than 40 suits and a state-court judge in Missouri refused in August to all former Neurontin users to combine claims into a class-action case.

The case is In re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629, U.S. District Court, District of Massachusetts (Boston).

Watch the video re-enactment of this case being prosecuted in the courtroom.  The names of the parties have been changed to protect the idiots.

Friday, October 8, 2010

How Many Drug Companies Are Ranked in the Top 100 Corporate Criminals of the 2000s?’

Here's my question: How many drug companies are ranked in the top 100 corporate criminals of 2000s?


Of all the work of the U.S. Department of Justice and the U.S. Department of Health and Human Services punishing these drug companies for wrongfully and illegally drugging children and getting paid for it, no one has stopped it.


When these federal decisions are handed down, the word does not get down to the community level.  You still have universities teaching the benefits of these illegal drugs for children, you still have unlicensed child protection workers making "recommendations" for children to be prescribed these illegal drugs, you even have court judgements mandating children to take these harmful drugs, despite the work of the federal government to protect the people.


So far, very few States have pursued Medicaid reimbursement of the wrongful and illegal marketing of these psychotropic drugs to children.  Utah Attorney General Mark Shurtleff was the first to lead the pack.


Utah Seroquel Risperdal Complaint


As there is no public dissemination on information of this kind, I do it and will keep doing it until I am made whole again and I challenge anyone, at any place, at any time to dispute what I say.

How Many Drug Companies Are Ranked in the ‘Top 100 Corporate Criminals of the 1990s?’




Posted By Dr. Mercola | October 08 2010 | 216 views


On August 19, Indiana Attorney General Greg Zoeller issued a call for whistleblowers to step forward and help the state and federal government crack down on health care and pharmaceutical industries that defraud the government of billions of dollars.

Announcing that the Indiana Medicaid program would recover $9.52 million from a record $2.3 billion federal lawsuit won against Pfizer, Zoeller said that fraud on Medicare and Medicaid each year is estimated to be a multi-billion-dollar problem.
He isn’t wrong: According to the Bureau of Investigative Journalists, the vast corruption that pharmaceutical companies are guilty of is fraught with fraud, cover-ups of fatal side effects, and huge kickbacks paid to doctors.
But that’s just the tip of the iceberg. The real truth is that it is much, much worse.
Sources:
Dr. Mercola’s Comments:
Fraud. Kickbacks. Price-setting, bribery and illegal sales activities, including a felony count of assisting the Arab League in acquiring documents on Israeli business activities. Add in all the doctored and back-dated documents, federal and civil lawsuits, and billions of dollars in government sanctions, fines, and penalties – not to mention the deaths – and you’d think it was the script for a thriller global action movie.
But no, it’s just Big Pharma at its deceitful best, dancing all the way to the bank while continuing to defraud the world of billions of dollars, and endangering the lives of regular people like you and me.
When I set out to investigate some of the criminal activities that the 12 largest pharmaceutical companies had been convicted of lately, I had a general idea of the hornet’s nest I would be stepping into.
But the amount of gross misconduct, fraud and deceit I found was so insidious, so massive, and so overwhelming that I decided to narrow my original 12 picks down to just five for the purposes of this article.
Because of the uniqueness of one particular company’s offense – a felony guilty plea to conspiring with the Arab League – I added a sixth.
‘Get Out of Jail Free’
I’m sure that each and every one of the drug companies who have had to pay fines for their criminal activities would argue that they’ve hardly been given a “get out of jail free” pass. But when you look at what they took, compared to what they’ve had to pay back, I think you’ll agree their punishment amounted to little more than a slap on the wrist.
The six companies I’m highlighting, in descending order of their annual revenues, are:
1.    Johnson & Johnson
2.    Pfizer
3.    Roche
4.    GlaxoSmithKline
5.    Novartis
6.    Baxter International
Size-wise, Baxter is actually way down the list at No. 17. But I felt this company’s offenses were so egregious that I just couldn’t ignore them. You may remember that last year at the height of the so-called flu pandemic, Baxter “mistakenly” mixed the lethal, live, biological weapon/virus, H5N1, with seasonal flu, then sent it to labs around Europe.
The potential disaster could have meant worldwide devastation, had it not been for the fact that the Czech Republic tested the vaccine before distributing it – and found it was a deadly cocktail.
Would it surprise you, then, that Baxter is the company that, in 1993, pled guilty to the felony count of violating U.S. laws prohibiting cooperation with the Arab boycott against Israel?
At the time, the Veterans Administration was so angered by this offense that they cited it as one reason why they wanted to suspend Baxter from all VA contracts for three years. The kicker was that the catalyst to the suspension was the VA’s contention that Baxter had“knowingly misled and provided false information to VA purchasing agents, in an attempt to get them to purchase Baxter products.”
In the end, Baxter agreed to pay more than $6.5 million in civil and criminal penalties to settle the Arab “mistake.”
Mistakes, Mistakes, Mistakes
You’ll find that “mistakes” happen often with Baxter.
From dozens of recalls of products that caused deaths and injuries, to at least 11 different guilty pleas to fraud and illegal sales activity, to more than 200 lawsuits – many of them stemming from selling AIDS-tainted blood to hemophiliacs – to more than $1.3 billion in criminal fines and civil penalties, Baxter over the years has racked up a record that makes Bonnie and Clyde look like angels.
While I don’t have space to name all the Baxter products that allegedly have caused deaths and/or injuries, a more recent product is itsblood thinner Heparin, the subject of a lawsuit filed by actor Dennis Quaid and his wife, who say their twins were injured by it.
Another Baxter product that caused deaths through the years was its tainted dialysis filters, which led to the company settling lawsuits of patients who died as a result of the tainted filters.
It’s no wonder why, in 1999, Baxter was named by AllBusiness.com as one of the “Top 100 Corporate Criminals of the 1990s!
Baxter earned its No. 87 spot on AllBusiness’ Top 100 Corporate Criminals list thanks to its guilty plea to dealing with the Arab League. But that place pales in comparison to (Hoffman La) Roche, which was crowned Corporate Criminal No. 1 for its $500 million criminal fine for leading a worldwide conspiracy to raise and fix prices and allocate market shares for certain vitamins sold in the United States and elsewhere.
The conspiracy lasted nine years, federal officials said – but it was the kind of “mistake” that was oft-repeated by a slew of drug companies during that decade.
Bribery, Fraud, Illegal Activities – They Just Keep Repeating
In all, 19 drug companies made AllBusiness.com’s Top 100 Corporate Criminals List for the 1990s.
Their fines totaled nearly $850 million – and that was just the settlements, not the actual losses the government alleged, for crimes such as defrauding Medicare, Medicaid, and even the FDA, as well as international price-setting, false claims, hiding serious problems with their drugs and, in one case (Ortho, a subsidiary of Johnson & Johnson), obstruction of justice and eight counts of persuading employees to destroy documents in a federal investigation!
What is sad and shocking is that this was just the tip of the iceberg, AllBusiness.com said in its report.
For every company convicted of health care fraud, there are numerous others who get away with ripping off Medicare and Medicaid, or face only mild slap-on-the-wrist fines and civil penalties when caught,”
I have to admit this literally makes me sick. If this is true – and I don’t doubt it one iota – can you imagine what the tally might be for the latest decade, which has seen record fines like the one that Pfizer was hit with last year?
Too Big to Fail?
You may recall that I wrote about this -- in the largest health care fraud settlement in history, Pfizer was ordered to pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra. The other drugs were the antipsychotic Geodon, the antibiotic Zyvox, and the anti-epileptic Lyrica.
Only a few years earlier, Pfizer had paid $430 million for illegally promoting uses of its seizure drug, Neurontin.
Yet, these are just a few examples of all the “mistakes” Pfizer has made through the years, making it very clear why AllBusiness.com named this company No. 17 in the Top Corporate Criminals for the 1990s.
Technically speaking, companies found guilty of fraud like this are banned from dealing with Medicare and Medicaid again. But, as I’ve already reported, do you think that happened with Pfizer?
Nope.
Instead, in a slap-on-the-wrist move that resembled the too-big-to-fail bank bailouts, federal prosecutors allowed Pfizer to avoid being sentenced for massive fraud and deception by letting them form a sham company to take the fall.
So, in the end, Pfizer’s “imaginary friend” Pharmacia & Upjohn shouldered the conviction, even though it had never sold any drugs. As CNN found, “the subsidiary is nothing more than a shell company whose only function is to plead guilty.”
And Pfizer got off scot-free, except for that little $2.3 billion fine that amounted to just three months’ profits.
And Then There’s Merck
Merck is another branch of Big Pharma with a long list of deaths to its credit. It was five years before Merck made its $30 billion recall of Vioxx that I warned my readers that this pain killer might be a real killer for some people.
As people began to die from heart attacks, strokes, and blood clotting disorders, I didn’t like being right. But I hated that after it was over, and the drug had been pulled, that Merck appeared to pick up the pieces painlessly – pun intended – by getting a new drug fast-tracked and on the market, lickety-split.
That drug is Gardasil, a vaccine that so far has been linked to thousands of adverse events and at least 49 unexplained deaths. It’s a situation that the FDA and CDC have been denying repeatedly, keeping their heads buried in the sand even as the adverse reports mount.
Merck has had other problems through the years, with more than $5.5 billion in judgments and fines levied against it. But like Pfizer, apparently somebody thinks this company is also “too big to fail.”
Johnson & Johnson: Just Another Drug Gang Member
As I mentioned earlier, this company made the 1990s Corporate Criminal list for deliberately destroying documents related to a criminal investigation case on one its products.
You probably don’t need to be reminded of all the recalls Johnson & Johnson has had over the years with its pain products, specifically Motrin, Tylenol and Fentanyl (pain killer patches). The fact that Johnson & Johnson has paid out over $1 billion in the last few years in fines and judgments probably comes as no surprise either.
But did you know that just recently (in May) the company pleaded guilty to illegally promoting its epilepsy drug Topamax for psychiatric purposes, and in so doing, settled a civil lawsuit in the case for $75 million?
You probably didn’t realize, either, that in January the US Dept. of Justice accused Johnson & Johnson of paying tens of millions of dollars in kickbacks to Omnicare Inc to buy and recommend Johnson & Johnson drugs.
This latest scheme is the subject of a federal lawsuit that has 18 states suing not just Omnicare, but 14 other major drug companies, alleging that they ran this scheme together.
The lawsuit’s been filed under the federal False Claims Act and, yes, Merck, Pfizer, Roche, Johnson & Johnson, and GlaxoSmithKline are all in there with Omnicare. Watch for news of this lawsuit in the upcoming months – but in the meantime, think about this: in the wake of all this hassle, Omnicare’s CEO Joel Gemunder has quit, but not without remuneration.
But again, this is just the tip of an iceberg.
GlaxoSmithKline: 1,500 Deaths Alleged
At more than $5 billion in fines and judgments, GlaxoSmithKline is treading the same muddy waters as Merck, especially since its HPV vaccine counterpart, Cervarix, has its own share of adverse reactions and alleged deaths being reported around the world.
GSK’s most recent “mistakes” stem from its diabetes drug, Avandia, which the FDA on September 23 decided to “regulate” – a little – but not withdraw, leaving Avandia as a “mistake” that is still ongoing.
In my research for this article, I also discovered that Avandia topped the list of drugs linked to fatal adverse events in 2009, according to an analysis of U.S. Food and Drug Administration records. With a staggering 1,354 deaths reported to the FDA in 2009 alone, it’s hard to believe that this drug is still even in discussion!
But, like the others I investigated, GSK also has made hundreds of millions of dollars in settlements for fraud cases and pricing disputes, as well as judgments won by the federal government in Medicare and Medicaid fraud suits.
Roche: No. 1 in AllBusiness.com’s Corporate Criminal Book
Roche’s offenses have been ongoing over the years in its companies and affiliates around the world. Most recently, in March, Roche suspended a clinical trial for a rheumatoid arthritis and lupus drug after serious infections, some of them fatal, were reported with it.
Officials reported that the trial was stopped because “opportunistic” infections like those found in the trials are not normal in healthy individuals. Sadly, that information was too late for 15 Japanese patients, who died after taking one of Roche’s approved arthritis medicines, Actemra.
But that’s not the end of deaths related to Roche products: Another Roche drug, Posicor, was withdrawn in 1998 after reports of at least 140 deaths linked to harmful interactions of Posicor with other drugs.
It’s no wonder that Roche has had to pay out nearly $2 billion in judgments and fines over the years, with thousands of individuals suing them. But before I move on, let me remind you that Roche also manufactures the CDC’s and FDA’s favorite flu stand-by, Tamiflu.
And in case you’ve forgotten, Tamiflu was blamed for the deaths of 18 Japanese children in 2007, and the subject of a warning by the Japanese Ministry of Health not to give this drug to children ages 10 to 19.
With a record like this, you would think that Roche and the rest of the drug king pins known as Big Pharma would have just a little shame over what they’ve done over the years. But, since the offenses just keep coming, and since states like Indiana have to keep on begging for whistleblowers to step forward, it’s apparent that Pharma’s sense of shame is nonexistent.
It seems fitting then, to end with this New York Times headline from 1999, when Roche was the subject of the price-fixing scandal that earned its No. 1 Corporate Criminal spot on AllBusiness.com’s list:
Roche Officers Say Scandal Is a Surprise.” Yes, they proclaimed innocence, even while the federal government was busy yanking their hands right out of the cookie jar.
Scam-Buster Efforts by States and the Feds Continue
Fortunately, states’ attorneys general like Zoeller are gaining ground in gathering support for routing out the criminal acts that Big Pharma continues to perpetuate.
More and more, organizations like the Bureau of Investigative Journalism, the False Claims Act Legal Center, and Politicol News are starting to investigate and publicize the illegal – and criminal – actions that these companies have been getting away with for years.
Thanks to the federal False Claims Act, state and federal investigators have a gun that they can use to hunt down and prosecute these heinous crimes with. If you visit the False Claims Act Legal Center website, you’ll get a hint of just how much this type of corporate has been going on.
But again, it’s just a hint, just the tip of an iceberg. What it does prove is that Big Pharma can’t be trusted – and they have the criminal history to prove it.
What’s most shocking, though, is that even when they get caught with deaths on their hands, along with the money in the cookie jar of price-fixing, fraud and deceit, is that like Pfizer, their punishments appear to be just little slaps on the wrist.
Apparently, they are too big to nail; too big to fail. So, like Baxter, instead of shutting down, they cough up a pittance in comparison to what they took, and continue onward with their government contracts for vaccines and other drugs.
It’s encouraging that Health and Human Services Secretary Kathleen Sebelius in July announced the formation of the Healthcare Fraud Prevention and Enforcement Action Team, which together with the Department of Justice, US Attorneys’ Offices and other federal agencies will target healthcare and drug fraud.
But, as Indiana Attorney General Greg Zoeller said, it’s going to take more than that. So, whistleblowers, come out and help in this crusade. It’s time to hold Big Pharma’s career criminals accountable.

Sunday, September 12, 2010

Too Big To Nail, Too Big To Fail

Of course Big Pharma is too big to nail because it is too big to fail. Just as we saw with some of the powerhouses of the banking and financial sectors such as AIG and Goldman Sachs which were too big to fail, the same applies to the pharmaceutical industry.

Just like the child welfare industry, paying fines, in the form of Federal Financial Participation Rate decreases, it is a far more cost-effective business practice than coming into compliance.

Just like the child welfare industry, it it too big to nail and too big to fail.



Pfizer too big to nail

But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It's a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.

Big plans for Bextra
The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.
Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.

But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.

Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.

If we prosecute Pfizer ... a lot of the people who work for the company who haven't engaged in criminal activity would get hurt.

--Mike Loucks, federal prosecutor
But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe.

Doctors as pitchmen
Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.

But an internal marketing plan called for training physicians "to serve as public relations spokespeople."

According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, "They pushed the envelope so far past any reasonable interpretation of the law that it's simply outrageous."

Pfizer's chief compliance officer, Doug Lanker, said that "in a large sales force, successful sales techniques spread quickly," but that top Pfizer executives were not aware of the "significant mis-promotion issue with Bextra" until federal prosecutors began to show them the evidence.
By April 2005, when Bextra was taken off the market, more than half of its $1.7 billion in profits had come from prescriptions written for uses the FDA had rejected.

Too big to nail
But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer's collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders. 

"We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients," said Lewis Morris of the Department of Health and Human Services.
So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.

The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company

Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.

An imaginary friend
I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one.
--Doug Lankler, Pfizer's chief compliance officer,
Two years later, with Bextra, the shell company once again pleaded guilty. It was, in effect, Pfizer's imaginary friend stepping up to take the rap.

"It is true that if a company is created to take a criminal plea, but it's just a shell, the impact of an exclusion is minimal or nonexistent," Morris said.

Prosecutors say there was no viable alternative.
"If we prosecute Pfizer, they get excluded," said Mike Loucks, the federal prosecutor who oversaw the investigation. "A lot of the people who work for the company who haven't engaged in criminal activity would get hurt."

Did the punishment fit the crime? Pfizer says yes.
It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected.

It paid a billion dollars more to settle a batch of civil suits -- although it denied wrongdoing -- on allegations that it illegally promoted 12 other drugs.

In all, Pfizer lost the equivalent of three months' profit.

It maintained its ability to do business with the federal government.

Pfizer says it takes responsibility for the illegal promotion of Bextra. "I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one," said Doug Lankler, Pfizer's chief compliance officer.

To prevent it from happening again, Pfizer has set up what it calls "leading-edge" systems to spot signs of illegal promotion by closely monitoring sales reps and tracking prescription sales.

It's not entirely voluntary. Pfizer had to sign a corporate integrity agreement with the Department of Health and Human Services. For the next five years, it requires Pfizer to disclose future payments to doctors and top executives to sign off personally that the company is obeying the law.
Pfizer says the company has learned its lesson.

But after years of overseeing similar cases against other major drug companies, even Loucks, isn't sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large.

"I worry that the money is so great," he said, that dealing with the Department of Justice may be "just of a cost of doing business."

Thursday, April 29, 2010

Pfizer Geodon Tested on Kids

The Pfizer Geodon Trial And Physician Mishaps

By Ed Silverman
April 28, 2010

Earlier this month, the FDA sent Pfizer a warning letter for failing to properly monitor pediatric clinical trials in which at least 13 children with bipolar disorder experienced overdosing that led to restless legs, tremors, involuntary facial movements and a serious skin disorder.

This is a big problem for the drugmaker, since Pfizer hopes to receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials. But the dosing scandal could prompt the FDA to request further trials, which would require so much additional time that exclusivity would likely be lost, since the basic Geodon patent expires in 2012. This would also delay pediatric approval, which would expand the possibilities for a drug that generated $1.1 billion in sales last year.

But who were some of the doctors involved? …

…there was Sohail Punjwani, who was cited for numerous instances in which the wrong dosage was given children. Punjwani ran one of three sites that were responsible for 40 patients receiving incorrect doses, or 16 percent of the kids involved, and half of them were given more than the maximum tolerated dose for the trial…

Punjwani has made headlines in Florida, where he is based, for treating 7-year-old Gabriel Myers, who hanged himself with a shower cord in a foster home. The boy’s death prompted a probe by a Department of Children & Families task force and proposed legislation before the Florida Senate. He did not respond to messages.

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Note: The FDA warning letter to Pfizer states that informed consent was not obtained in these clinical trials. See letter here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm208976.htm


The FDA warning letter to Punjwani can be found here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202862.htm