Wednesday, September 15, 2010

Forest Labs Pulls an AstraZeneca as the DOJ let's crime spree continue with another meaningless fine



Forest Labs Pulls an AstraZeneca as the DOJ "Department of Justice" let's crime spree continue with another meaningless fine to Pharmaceutical Drug Cartel Member pimping drugs to Kids

You may have picked up news reports about Forest Labs pleading guilty to drug marketing crimes including promoting a drug not approved by the FDA. Which is pretty crazy in itself, since the FDA will just about rubber stamp any drug if the right palms are greased to get a corrupted approval committee set in place. I guess Forest Labs decided it was more profitable to just bypass the whole rubber stamp process and go right after the profits. They know the fines they will incur is like a small drop in the bucket compared to the huge profits to be had promoting off label to kids. They also know their business model and massive profitability would go pretty much uneffected if and when they were caught. In fact none of their management team including the CEO have any inkling of fear related to criminal prosecution or jail time.

So once more a large pharmaceutical corporation subverts real justice and walks away with little more than a tiny slap on their balance sheet. The veil has been pretty much pulled away by now, as those elites in Washington DC politics and in the White House are up to their corrupted dirty necks in this nasty mire while still collecting large checks and influence money from the very criminals they are supposed to be prosecuting & protecting us from.

Maybe next time a police officer pulls you over for that speeding ticket or for talking on your cell phone you should remember to tell them your protected under the corporate umbrella of Big Pharma. They will probably get a stunned deer in the highlights glazed look coming across their face while walking back to their awaiting cruiser whimpering in shame. SURE, THAT WILL HAPPEN!

In fact when that next Tax bill comes along, just send a letter to the IRS saying you can't pay it this time, but your willing to sign an integrity agreement to pay next time around if that's OK. I wonder how lenient Uncle Sam would be with you Joe/Jane Citizen? YEAH RIGHT, You'd be singing those sad prison blues I'm afraid.

You might want to know this particular case dates back to the 1990's when the FDA knew all to well the shenanigans Forest Lab was pulling off. Yet, the FDA did nothing but send out a patented meaningless warning letter and did nothing else.

The FDA is worthless as a government agency or safety mechanism for the American people can get. It's time to stop throwing tax payer money at just another useless wasteful boondoggle. Time for the FDA and all their useless bureaucrats to hit the unemployment line permanently.

Don't you the American Citizen believe it's about time for some Pharmaceutical CEO's to spend serious time behind bars. I would ask if you think it's about time for the American public to demand that our government start protecting their citizens from a rampant corporate crime spree or get out of the way so we the people can do the job.


Is it just me, or are these two pictured below perfect evil twins?


Howard Solomon Forest Labs CEO

&


Dr. Evil CEO of Evil Enterprise

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From Bloomberg news:

http://www.bloomberg.com/news/2010-09-15/forest-unit-agrees-to-plead-guilty-pay-313-million-in-levothroid-cases.html


Forest Unit Pleads Guilty to Marketing Thyroid Drug, Will Pay $313 Million

A Forest Laboratories Inc. unit agreed to plead guilty to distributing its Levothroid thyroid drug before it was approved by the Food and Drug Administration and pay $313 million, the U.S. Department of Justice said.

The allegations also involved illegal promotion of Celexa for use in treating children and adolescents suffering from depression, the Justice Department said in a statement. The Forest Pharmaceuticals unit also agreed to settle allegations it caused false claims to be submitted to federal health care programs for Levothroid, Celexa and Lexapro.

The company will pay a $150 million criminal fine, will forfeit $14 million, and pay more than $149 million to settle the False Claims Act allegations, according to the statement.

“Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the FDA and the American public,” U.S. Attorney Carmen Ortiz in Boston said in the statement. “The company knew that it did not have FDA approval to distribute Levothroid.”

Howard Solomon, chief executive officer of New York-based Forest Laboratories, said in a statement, “We are pleased to bring closure to this long-running investigation.”

“We remain dedicated to ensuring that we operate in full compliance with all laws and regulations, and that our employees uphold the highest principles of integrity, honesty and ethics,” he said.

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From Jim Edwards @ BNET http://bit.ly/cxM1wJ

$1,000 a Pop: How Forest Labs Bribed Doctors to Prescribe Antidepressants to Kids

Forest Labs (FRX) appears to have initially underestimated how much it needed to pay the feds to go away: In 2009, the company said it had set aside $170 million in case it needed to settle a Department of Justice investigation of the kickbacks it paid in its marketing of Celexa and Lexapro, two antidepressants. Today, the company paid $313 million to wrap up the probes.

Forest’s management is used to lavish spending, however, as the whistleblower complaints behind the settlement allege.

The meat of Forest’s wrongdoing is that the company promoted Celexa for children even though the FDA had specifically rejected the drug for kids, and even though European data showed it was not useful in youths. The company did something similar with Lexapro — one pharmaceutical sales rep recommended crushing up Lexapro into apple sauce in order to make it more palatable to children.

Forest overcame resistance to the pediatric use of its antidepressants by bribing doctors with cash and gifts, the lawsuits alleged. Among the goodies Forest handed out were:

  • Tickets to St. Louis Cardinals games.
  • A $1,000 certificate to Alain Ducasse, one of the best (and most expensive) restaurants in New York, according to this suit.
  • A trip to see a George Carlin concert. (They’re antidepressants and he’s funny, geddit?).
  • $1,000 in cash to attend dinner at the Doral Park Country Club in Miami.
  • A trip to the Great Escape amusement park in New York.
  • Tickets to The Nutcracker at the Paper Mill Playhouse in Millburn, N.J., according to this suit.

The settlement, in which Forest pleads guilty to the accusations against it, also implies that one unnamed Forest executive lied to Congress in September 2004 — which is in itself a crime.

This is about the quality of Forest management’s decision-making. Given that Forest’s marketing plan required making false statements to a Congressional inquiry, it is perhaps not surprising that it also underestimated the size of its legal liabilities.

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And then more at soulful sepulcher

with multiple in-depth post

The US is constantly being duped, ripped off and mocked by the pharmaceutical industry. As taxpayers you should be outraged this is allowed to get this far. Just WHO watches over our health care for drug safety? How the hell does a drug get illegally marketed and sold for use to Medicaid providers before the drug was approved by the FDA? The FDA is worthless! ----

August 07, 2003

WARNING LETTER

Forest Laboratories, Inc. 07-Aug-03-Warning letter

August 07, 2003 WARNING LETTER CIN-03-16736 SENT VIA FEDERAL EXPRESS Howard Solomon, Chief Executive Officer Forest Laboratories, Inc. 909 Third Avenue New York, NY 10022 Dear Mr. Solomon: This letter is in reference to the inspection of your finished pharmaceutical manufacturing plant, Forest Pharmaceuticals, Inc., located at 5000 Brotherton Road, Cincinnati, OH 45209, conducted on January 28 - February 20, 2003, and to your firm?s continued marketing of Levothroid? (levothyroxine sodium tablets, USP) without an approved application.
Levothyroxine sodium tablets are drugs within the meaning of Section 201 (g) and are new drugs within the meaning of Section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act). New drugs may not be introduced in interstate commerce unless there is an approved application under the provisions of Section 505 on file with the Food and Drug Administration (the agency). AND We received a letter from Karl Fricke, Ph.D., Director of QC/QA, and Gregory Yurchak, Plant Manager, dated March 19, 2003, which was in response to the observations listed on the Form FDA-483 issued at the close of the inspection. The corrective actions offered in Mr. Fricke?s response were taken into account in preparing this letter. This letter is not intended to be an all-inclusive list of deficiencies at your facility. A copy of the Form FDA-483 is enclosed for your information. It is your responsibility to assure that all products distributed by your firm meet the requirements of the Act and its implementing regulations. We request that you notify this office in writing within 15 working days of receipt of this letter stating the action you will take to discontinue the marketing of your Levothroid? (levothyroxine sodium tablets, USP) drug products and to bring your other drug products into compliance. Your reply should include an estimate of the amount of Levothroid? that is in inventory under your control. Failure to achieve prompt correction may result in regulatory action without further notice. The Act provides for seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products. Your reply should be sent to the attention of Charles S. Price, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. Any questions regarding this letter may be directed to Mr. Price at telephone (513) 679-2700 extension 165. Sincerely, /s/ Deborah Grelle

2 comments:

betasheep said...

It's just a few cents lost for every dollar gained and simply boils down to the cost of doing business. Innocent lives be damned.

If you think the federal government is going to do anything about the criminal conduct of its contractors and suppliers, think again.

Just read the history of General Electric and the Defense Department. GE has regularly gouged the government in its defense work. Its criminal behavior has been duly noted, cited and fined by regulators. And then it shows up to bid on the next round of defense contracts to do it all over again. Wash. Rinse. Repeat.

And GE is just one example out of many.

Sadly, it seems the drug companies have taken a valuable lesson from this. With the regulators in their back pockets, they think they're too big and too important to be bothered by the little man's laws :-(

Mark p.s.2 said...

I believe it is known psychiatric med/drugs are not working to keep mental illness away. The percentages of M.I.are always growing.
It reminds me of the rocket program being sold to Hitler as being successful, when it wasn`t. The top nazi brass were only shown the successful rocket launches.
In time they might have got superior technology into production and won the war.
Perhaps the control of the people with legal pharma meds-drugs will work to keep the country/world continuing to shop, and search for happiness and fulfillment through (vanity-narcissism) of material wealth. Consuming and throwing away and the thrown away plastic killing everything as it doesn`t fit into nature, natures cycle of life.
What happened to the past human civilizations?

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