Weekly Roundup - Living On Nothing Edition [Survival Today

Did you hear about the guy that lives on nothing? No seriously, he lives on zero dollars a day. Meet Daniel Suelo, who lives in a cave outside Moab, Utah. Suelo has no mortgage, no car payment, no debt of any kind. He also has no home, no car, no television, and absolutely no “creature comforts.” But he does have a lot of creatures, as in the mice and bugs that scurry about the cave floor he’s called home for the last three years.

To us, Suelo probably sounds a little extreme. Actually, he probably sounds very extreme. After all, I suspect most of you reading this are doing so under the protection of some sort of man-made shelter, and with some amount of money on your person, and probably a few needs for money, too. And who doesn’t need money unless they have completely unplugged from the grid? Still, it’s an amusing story about a guy who rejects all forms of consumerism as we know it.

How to Brew Your Own Beer and Maybe Save Some Money. A fantastic introduction to home brewing, something I’ve never done myself, but always been interested in trying. (@Generation X Finance)

Contentment: A Great Financial Principle. If I had to name one required emotion for living a frugal lifestyle it would be contentment. Once you are content with your belongings and your lot in life you can ignore forces attempting to separate you from your money. (@Personal Finance by the Book)

Use Energy Star Appliances to Save On Utility Costs. I enjoyed this post because it included actual numbers, and actual total savings, from someone who upgraded to new, energy star appliances. (@The Digerati Life)

Over-Saving for Retirement? Is it possible to “over-save” for retirement? Yes, I think so. At some point I like the idea of putting some money aside in taxable investments outside of retirement funds, to be accessed prior to traditional retirement age. (@The Simple Dollar)

40 Things to Teach My Kids Before They Leave Home. A great list of both practical and philosophical lessons to teach your kids before they reach the age where they know everything. I think that now happens around 13 years-old. (@My Supercharged Life)

Index Fund Investing Overview. If you are looking for a place to invest with high diversification and relatively low fees (for broader index funds with low turnover), index funds are a great place to start. (@Money Smart Life)

5 Reasons To Line Dry Your Laundry. My wife and I may soon be installing a clothesline in our backyard. In many neighborhoods they are frowned upon - one of the reasons I don’t like living in a neighborhood. I digress. One of our neighbors recently put up a clothesline, and we might just follow his lead. (@Simple Mom)

* 4 Quick Tips for Getting Out of a Rut * Young and Cash Rich * Embracing Simple Style * First Trading Experience With OptionsHouse * The Exponential Power of Delayed Consumption * How Much Emergency Fund is Enough? * 50 Questions that Will Free Your Mind * Save Money On Car Insurance

http://www.fda.gov/Safety/Recalls/ucm186494.htm

Limited Voluntary Recall of Country Acres® Home Grown Turkey & Quail Starter

Company Contact:
Jeanne Forbis, Communications Director
651-481-2071

FOR IMMEDIATE RELEASE - (Shoreview, Minn.) Oct. 13, 2009 … Land O’Lakes Purina Feed LLC is recalling a single lot of Country Acres® Home Grown Turkey & Quail Starter 30% BMD 200 feed due to a lower than formulated protein level. During the investigation of a customer complaint, it was discovered that there was a manufacturing error in one lot which resulted in feed being manufactured with a lower protein level. Low protein levels can adversely affect bird growth and development and, in extreme cases, increase the potential for bird mortality. Only a single lot of this one product (distributed in 50-pound bags) is included in the recall. No other products or lot numbers are affected. The product and lot number being recalled is:
Formula No.

Item No.

Description

Lot No.
59FC 0015447 Country Acres® Home Grown Turkey & Quail Starter 30% BMD 200 9AUG20ARC1

Lot numbers are printed on the sewing strip of each bag. They are interpreted as follows:

9 = Year … AUG = Month … 20 = Day of Month … ARC1 = Plant Code

The product being recalled was distributed to dealers in Louisiana, southern Arkansas, eastern Texas and southern Mississippi. Dealers have been contacted and asked to hold this product (bearing the affected lot number) and to notify and retrieve the recalled product from customers. Customers should discontinue feeding the product and return any unused portions to their dealer.

Customers who purchased this product will receive a full refund. For more information on the product recall, customers should contact their local feed dealer or Customer Service at 1-800-227-8941 between the hours of 8:30 a.m. and 4:00 p.m. Central Time.

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RSS Feed for FDA Recalls Information [what’s this?]

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Page Last Updated: 10/14/2009

http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/default.htm

Genetically Engineered Animals

Picture of goats, a chicken, a cow, and pigs

Introduction

Genetic engineering is a targeted and powerful method of introducing desirable traits into animals using recombinant DNA (rDNA) technology. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms.

In January, 2009, the Food and Drug Administration issued a final guidance for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.
-
What is FDA Doing?

Final Guidance Released 1/15/2009

* FDA Issues Final Guidance on Regulating Genetically Engineered Animals
* CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 128KB)
* Fact Sheet
* General Q&A
* FDA’s Response to Public Comments
* Genetically Engineered Animals Diagram
* January 15, 2009 Transcript for FDA’s Media Briefing on FDA’s Release of a Final Guidance for Industry on the Regulation of Genetically-Engineered Animals (PDF - 65KB)
* Notice: Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs

TED Talks: Carolyn Steel: How food shapes our cities

“The question of how to feed cities may be one of the biggest contemporary questions,
yet it’s never asked: we take for granted that if we walk into a store or a restaurant,
food will be there, magically coming from somewhere. Yet, think of it this way:
just in London, every single day, 30 million meals must be provided. Without a reliable
food supply, even the most modern city would collapse quickly. And most people today
eat food of whose provenance they are unaware.

Ho Chi Minh (HCM) City, Vietnam - Agriculture urged to go Urban

HCM CITY - Switching from traditional crops to urban farming is an inevitable process
due to the rapid urbanisation taking place in HCM City, an expert has said.

Speaking at a conference in the city’s Binh Chanh District yesterday, Truong Hoang,
deputy director of the municipal Steering Committee for Agriculture and Rural Development,
said farmlands have been shrinking by an average of 1,176 ha every year since 2000
and what is left is not enough for normal agriculture.

1749 - Kitchen Gardens in French Canada

Peter Kalm’s Travels into North America
From the earliest days of settlement in North America, town and country Kitchen
Gardens were essential to the survival of the new inhabitants. One traveller, the
Swedish naturalist Peter Kalm, has written extensively about what he saw during
his travels in French Canada in 1749 (Volume 3) and he spends considerable time
writing about the plants that were grown and used in people’s gardens.

His three volume Travels into North America : containing its natural history, and
a circumstantial account of its plantations and agriculture in general, with the
civil, ecclesiastical and commercial state of the country, the manners of the inhabitants,
and several curious and important remarks on various subjects is a treasure trove
of fascinating history of life in North America 250 years ago.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

All these stories here:
City Farmer News [http://rs6.net/tn.jsp?et=1102765733494&s=1304&e=001OGq0cJv0DsYpcgCy8l1RnDSSpnjSHmJY1JNx4B1wwh4GlZJnFuxpbjmusapwXTVeEPNDMtIvi5ZtPFjPbSmJ2SngRi3ytAeMlaTnoJxciJWIs0hN895kwA==]
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Michael Levenston
City Farmer - Canada’s Office of Urban Agriculture

Poblano and Mushroom Tacos
Posted by: “~*Piper*~”

Poblano and Mushroom Tacos

2 tablespoons vegetable oil, divided
1 fresh poblano chile, halved, seeded, thinly sliced into long strips
1/2 small red onion, sliced
3 ounces crimini (baby bella) mushrooms, thinly sliced (about 1 1/4 cups)
1 teaspoon ground cumin
4 corn tortillas
4 thin slices Monterey Jack cheese
Chopped fresh cilantro
Crumbled feta or Cotija cheese
Assorted toppings (such as shredded lettuce, diced tomatoes, and hot sauce or salsa)

Heat 1 tablespoon vegetable oil in large nonstick skillet over medium-high heat.
Add poblano chile, red onion, and mushrooms; sauté mixture until brown, about 5 minutes. Mix in ground cumin. Season to taste with salt. Transfer mixture to medium bowl.

Heat remaining 1 tablespoon vegetable oil in same skillet over medium-high heat.
Add tortillas in single layer, draping up sides of skillet to fit. Divide
mushroom mixture among tortillas, mounding on only 1 side. Place slice of
Monterey Jack cheese atop filling in each tortilla. Fold plain tortilla halves over filling and press firmly. Cook until tortillas are brown, about 1 minute per side. Transfer tacos to plates. Open tacos; sprinkle with chopped cilantro, crumbled feta or Cotija cheese, and toppings.

________________________________________________________________________
________________________________________________________________________
2. White Kidney Beans with Roasted Peppers and Olives
Posted by: “~*Piper*~”

White Kidney Beans with Roasted Peppers and Olives

1 19 oz. can white kidney beans, rinsed, and drained well
2 green onions, finely diced
2 medium roasted red peppers, halved and sliced
1/2 cup black olives
2 tbsps. olive oil
1 garlic clove, crushed
pinch cayenne pepper and sugar
1 tsp. herbes de Provence
1 tsp. ground cumin
2 tbsps. lemon juice
salt and black pepper, to taste

Place beans, onions, peppers and olives in a bowl and gently mix to combine.
Combine olive oil, garlic and seasonings in a bowl.
Gently toss dressing into salad. Cover and allow flavours to meld in the fridge for 20 minutes, or longer if possible.
Makes 4 servings.

This is another great group owned by *~Tamara~*

To visit group on the web, go to:
http://groups.yahoo.com/group/Simply-Spicy/

New biological pest control laboratory at the forefront of a global revolution in
urban food production.

A new biological pest control laboratory opening today at Kwantlen Polytechnic University
will place B.C. at the forefront of a global revolution in urban food production.

The lab - the first of its kind in North America - will develop insect-and microbe-based
pest control systems for use on small-scale farms and in areas where farming and
housing share space.

Cities all over the world and here in B.C. are integrating farming into the urban
environment, from smallacreage market gardens to green-roof food production and
community gardens in parks and sustainable housing developments.

But for people and commercial food production to coexist in a densely populated
urban environment, alternatives must be found to replace chemical pest control,
said Deborah Henderson, director of Kwantlen’s Institute for Sustainable Horticulture.

The City Farmers of Thomas More’s Utopia - 1516

“There lie gardens behind all their houses. These are large, but enclosed with
buildings, that on all hands face the streets, so that every house has both a door
to the street and a back door to the garden.

“They cultivate their gardens with great care, so that they have both vines, fruits,
herbs, and flowers in them; and all is so well ordered and so finely kept that I
never saw gardens anywhere that were both so fruitful and so beautiful as theirs.

And this humour of ordering their gardens so well is not only kept up by the pleasure
they find in it, but also by an emulation between the inhabitants of the several
streets, who vie with each other. And there is, indeed, nothing belonging to the
whole town that is both more useful and more pleasant.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

All stories here.
City Farmer News [http://rs6.net/tn.jsp?et=1102768990825&s=1304&e=001ehMOoDHSKcaB5gK7izdhSpl5XuZBifIk8pH2rzQCLDSG16cuIm5acbL7qNBDePBdm4YKg_O_vSocHLgBseg8omx7QQDed_oriJ5t0mWJz0Pv3K2ePHDuRA==]
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Michael Levenston
City Farmer - Canada’s Office of Urban Agriculture

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm

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FDA NEWS RELEASE

For Immediate Release: Oct. 15, 2009

Media Inquiries: Christopher Kelly, 301-796-4676 christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet

The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.

One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.

These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.

“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.

Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.

The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.

The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.

The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products.

Consumers can also visit FDA’s Web site for tips about how to protect themselves when buying medicines online.

Additional Information
FDA 2009 H1N1 (Swine) Flu Page
Fraudulent H1N1 Products Widget

Live links at site pages...

U.S. ATTORNEY NEWS RELEASE: PINE BLUFF DOCTOR INDICTED ON MISBRANDING, HEALTH CARE FRAUD, & MONEY LAUNDERING CHARGES

For a copy of the news release, visit the U.S. Attorney’s web site.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186423.htm

U.S. ATTORNEY NEWS RELEASE: TWO INDICTED FOR SENDING MORE THAN 15,000 MISBRANDED DRUGS TO CUSTOMERS

View the PDF version of the news release.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186437.htm

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FDA NEWS RELEASE

For Immediate Release: Oct. 13, 2009

Media Inquiries: Chris Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets
Four Companies Required to Stop Making and Distributing Illegal Opioid Pain Relievers

The U.S. Food and Drug Administration today warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.

These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.

“Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling, and quality. Removing unapproved products that do not meet those standards is an FDA priority,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA urges drug companies to ensure all drugs they make and market have appropriate FDA approval.”

The names of the products and the manufacturers and distributors that received the warning letters are:

* Codeine Sulfate Tablets, 30 mg, 60 mg – Lehigh Valley Technologies Inc., Allentown, Penn.
* Codeine Sulfate Tablets, 30 mg, 60 mg – Cerovene Inc., Valley Cottage, N.Y.
* Codeine Sulfate Tablets, 30 mg – Dava International Inc., Fort Lee, N.J.
* Codeine Sulfate Tablets, 30 mg, 60 mg – Glenmark Generics Inc. USA, Mahwah, N.J.

Companies receiving the warning letters have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs. Manufacturers have 90 days to cease manufacturing of new product, and distributors have 180 days to cease further shipment of existing products. Previously manufactured unapproved products may still be found on pharmacy shelves for a period of time.

Today’s action is part of the FDA’s initiative against the marketing of unapproved drugs, announced in June 2006. At that time, the agency published a Compliance Policy Guide describing the FDA’s risk-based enforcement approach to unapproved products.

“Doctors and patients often find that some drugs on the market do not have FDA approval,” said Deborah M. Autor, director of CDER’s Office of Compliance. “This lack of approval undermines the FDA’s process to ensure that safe and effective drugs are available to the U.S. public.”

Consumers who rely on opioid analgesics for pain relief have access to products that have been evaluated by the FDA and determined to be safe and effective for use. There are other FDA-approved drugs, including different opioid analgesics, which can be used to relieve pain. Consumers should consult a health care professional for detailed guidance on treatment options.

For additional information, including copies of the warning letters that identify the firms involved and the names of their products, see the FDA’s Unapproved Drugs Web page/Enforcement Actions.

For more information

Drugs Marketed in the United States That Do Not Have Required FDA Approval

Drugs@FDA – Information on FDA-approved drugs

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186418.htm

http://www.fda.gov/Safety/Recalls/ucm186984.htm

TGF PRODUCTION LLC Issues An Alert On Uneviscerated Herring Salted

Company Contact:
Anzor Pichkhadze,
646-546-5847

FOR IMMEDIATE RELEASE - October 15, 2009 - TGF PRODUCTION LLC 191 CENTRE STREET BROOKLYN NY 11231 is recalling Herring Salted because the product was found to be uneviscerated.

The recalled Herring Salted was distributed nationwide in 1.3kg ( 2.86lb) round plastic containers with the code numbers 24.08.09 and 13.07.09. The Herring Salted is a product of Russia.

The Herring Salted was sampled by a New York State Department of Agriculture and Markets Food Inspector during a routine inspection. Subsequent analysis of the product by New York State Food Laboratory personnel confirmed that the Herring Salted was not properly eviscerated prior to processing.

The sale of uneviscerated fish is prohibited under the New York State Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish have been linked to outbreaks of botulism poisoning.

This product may be contaminated with Clostridium Botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness. Symptoms of botulism include blurred or double vision, general weakness, poor reflexes, difficulty in swallowing and respiratory paralysis.

No illnesses have been reported to date in connection with this problem. Consumers that have purchased Herring Salted are advised not to eat it and should return it to the place of purchase. Consumers with questions may contact TGF PRODUCTION LLC, at 646 546 5847.

http://www.fbi.gov/pressrel/pressrel09/topten_101609.htm

[Top FBI news releases]

For Immediate Release
October 16, 2009

Washington D.C.
FBI National Press Office
(202) 324-3691

FBI’s Top Ten News Stories for the Week Ending October 16, 2009

1. New York: Hedge Fund Managers, Fortune 500 Executives, and Management Consulting Director Charged in Historic Insider Trading Case

Six individuals were charged in connection with their alleged involvement in the largest hedge fund insider trading case in history. All are charged with participating in insider trading schemes that together netted more than $20 million in illegal profits. This case represents the first time that court-authorized wiretaps have been used to target significant insider trading on Wall Street. Full Story

2. New York: Forty-One Defendants Charged in Coordinated Mortgage Fraud Takedown Across New York State

An indictment was unsealed charging 41 defendants, in eight separate cases, with allegedly engaging in various mortgage fraud scams that defrauded lenders out of more than $64 million in home mortgage loans on more than 100 properties across New York State. Among those charged are six lawyers, seven loan officers, three mortgage brokers, an accountant, and a residential property appraiser. Full Story

3. Detroit: Chinese National Charged With Stealing Ford Trade Secrets

Xiang Dong Yu of Beijing, China was charged with theft of trade secrets, attempted theft of trade secrets, and unauthorized access to a protected computer. According to the indictment, Yu was a product engineer for the Ford Motor Company from 1997 to 2007 and had access to Ford trade secrets, including Ford design documents. Before his departure from Ford, Yu copied 4,000 Ford documents onto an external hard drive, including sensitive design documents. Yu also allegedly used stolen Ford design documents in an effort to obtain employment with a Chinese automotive company in 2005 and again in 2008. Full Story

4. Sacramento: Operation TRAPS Targets Internet Predators

Approximately 150 law enforcement officers from 26 federal, state, and local agencies participated in a two-day child predator sweep organized by the Sacramento FBI Cyber Crimes Task Force. The sweep, code named Operation TRAPS, targeted child predators and pornographers and was in support of the FBI’s Innocent Images National Initiative, a program designed to reduce the sexual exploitation and abuse of children over the Internet. Full Story

5. Kansas City: Leader of Asian Massage Parlor Scheme Sentenced for Coercing Prostitution, Money Laundering, Identity Theft

Ling Xu, the owner and operator of Asian massage parlors in Johnson County, Kansas, was sentenced to eight years and two months in federal prison for leading and organizing a criminal scheme to coerce her employees, whom she recruited from China, to engage in prostitution. Xu, who also pleaded guilty to money laundering and identity theft, is subject to deportation upon the completion of her sentence. Full Story

6. Philadelphia: Financial Fraudster Sentenced to 90 Months in Prison

Jason Bloom was sentenced to 90 months in prison for wire fraud stemming from a scheme to defraud homeowners, lenders, title insurance companies, and the City of Philadelphia of more than $1.7 million. Bloom engaged in this scheme from 2004 to 2008, acting as a settlement agent and title insurance agent for real estate sales and refinancings. Full Story

7. New Orleans: Man Convicted of Federal Hate Crime for Burning His Neighbors’ Home

Johnny D. Mathis pleaded guilty to firing three shots from a shotgun at the home of three Hispanic men and, after they fled, entering the home and setting a fire that burned it to the ground. Full Story

8. Chicago: Defense Contractor to Pay $25 Million to Settle Contract Fraud Claims

MPC Products Corp., a defense contractor based in Skokie, Illinois, agreed to pay the United States a $2.5 million criminal fine and an additional $22.5 million civil judgment to settle federal allegations that it overcharged the government in a series of military contracts extending over a decade, ending in 2005. The company also agreed to simultaneously resolve both criminal and civil matters. Full Story

9. New Haven: Former United Rentals Executive Admits to Conspiring to Falsify Company Books

John N. Milne pleaded guilty to one count of conspiracy to falsify the books and records ofUnited Rentals, Inc. while he served as its Chief Financial Officer. Full Story

10. Minneapolis: Packaged-Ice Company, Three Former Executives Plead Guilty to Customer Allocation Conspiracy

Arctic Glacier International Inc., a packaged-ice company headquartered in St. Paul, agreed to plead guilty and to pay a $9 million criminal fine for allocating customers. In addition, three of the company’s former executives pleaded guilty for their roles in the conspiracy to suppress and eliminate competition by allocating packaged-ice customers in the Detroit metropolitan area and southeastern Michigan. Full Story

http://boston.fbi.gov/dojpressrel/pressrel09/bs101609.htm

For Immediate Release
October 16, 2009 United States Attorney’s Office
District of Massachusetts
Contact: (617) 748-3100

Court Imposes Record Fine and Forfeiture of $1.3 Billion for Pharmacia & Upjohn Company’s Fraudulent Marketing of Bextra

BOSTON—PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc (“Pfizer”) today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead. PHARMACIA & UPJOHN COMPANY, INC. was sentenced by United States District Judge Douglas P. Woodlock to pay a criminal fine of $1.195 billion and a criminal forfeiture of $105 million, for a total criminal resolution of $1,300,000,000. This is the largest criminal fine ever imposed in the United States for any matter.

In addition, as announced on September 2, 2009, Pfizer agreed to pay an additional one billion dollars plus interest to settle civil allegations that it fraudulently promoted and marketed Bextra, as well as three other drugs in its portfolio, Geodon, an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, an anti-epileptic drug, as well as claims that it paid kickbacks for these, as well as other drugs, to induce physician prescribing. Pfizer also agreed to comply with the terms of a new and significantly expanded corporate compliance program, which seeks to ensure that in the future there are procedures and reviews in place to avoid, or, at a minimum, timely detect such violations.

At an earlier plea hearing, the prosecutor informed the court that had this case had gone to trial, the government’s evidence would have proven that:

When Bextra received its approval from the U.S. Food and Drug Administration (“FDA”) in November 2001, the FDA notified PHARMACIA & UPJOHN COMPANY, INC. that Bextra was approved for three indications: osteoarthritis (“OA”), adult rheumatoid arthritis (“RA”) and for the treatment of primary dysmennorrhea (“PD”). PHARMACIA & UPJOHN COMPANY, INC. had originally sought approval of Bextra for higher dosages for general acute pain, including surgical pain. However, the FDA declined to approve Bextra for these uses and for any dosage for arthritis above 10 mg., in part, because of safety concerns about Bextra. In particular, the FDA cited as a safety concern the results of a study of Bextra and its injectable form, parecoxib, used in patients undergoing coronary artery bypass graft surgery (the “CABG I” trial); the FDA specifically noted that there was an excess of serious cardiovascular events in the Bextra/parecoxib arm of the trial.

Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses - any use not specified in an application and approved by FDA.

Nonetheless, from in or about February 2002 through Bextra’s removal from the market in April 2005, PHARMACIA & UPJOHN COMPANY, INC., first through a co-promotion agreement with Pfizer, and then as a subsidiary of and with Pfizer (hereinafter together “PHARMACIA”), promoted the sale of Bextra for some of the very uses and dosages that the FDA had declined to approve - such as for general acute pain and surgical pain - and about which the FDA had raised specific safety concerns. It also promoted Bextra with false and misleading claims of safety and efficacy. Moreover, when so promoting Bextra, PHARMACIA did not inform physicians, customers and others that it had asked the FDA to approve Bextra for these uses, but that the FDA had specifically refused to do so in part because of safety issues, including potential cardiovascular risks. PHARMACIA did this in the following ways:

1. Headquarter Marketing Plans: PHARMACIA’s marketing team positioned Bextra for acute pain, surgical pain, and other unapproved uses and dosages, commissioned market research to test its sales materials, and confirmed these unapproved messages. In such documents, PHARMACIA marketing team stated as the “intended” use and message for Bextra that Bextra was for “acute pain.”
2. Field Force Implementation: PHARMACIA’s sales force promoted Bextra directly to physicians for these unapproved uses and dosages, including by drafting and distributing proposed physician standing orders and hospital wide protocols and pain pathways that called for unapproved uses of Bextra. The sales force also made false and misleading claims to physicians about Bextra’s safety and efficacy.
3. Payments and Other Remuneration to Physicians/Purported Consultants: PHARMACIA used so-called advisory boards, consultant meetings and other remuneration, including travel to lavish resorts, to promote Bextra to medical prescribers for unapproved uses and dosages and with false and misleading claims as to its safety and efficacy.
4. Sham Physician Requests for Off-Label Information: PHARMACIA’s sales force created sham physician requests for medical information in order to send unsolicited information to physicians about unapproved uses and dosages.
5. Distributing Samples for Unapproved Uses and Dosages: PHARMACIA provided promotional samples to surgeons and other medical prescribers who had no FDA-approved use for the Bextra samples, or at that dosage;
6. Control of Purportedly Independent Medical Education (”CME”): PHARMACIA sponsored purportedly independent CME to disseminate messages about unapproved uses of Bextra, including for acute and surgical pain.
7. Use of a Publication Strategy to Disseminate Off-label Messages: PHARMACIA initiated and paid vendors to draft articles about Bextra for unapproved uses without appropriate disclosures of PHARMACIA’s role.

As part of the Plea Agreement, PHARMACIA accepted responsibility for its illegal conduct and the United States agreed that PHARMACIA had fully cooperated in the investigation.

This case was handled by Assistant U.S. Attorneys Sara Miron Bloom, Susan M. Poswistilo and Zachary Cunha of the U.S. Attorney’s Office for the District of Massachusetts, Sanjay Bhambhani of the Department of Justice’s Civil Fraud section, Trial Attorney Jill Furman of the Justice Department Office of Consumer Litigation and Anne Walsh of the FDA General Counsel’s Office. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services, Federal Bureau of Investigation, Defense Criminal Investigative Service, the Office of Criminal Investigations for the Food and Drug Administration, the Veteran’s Administration’s Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management and the Office of the Inspector General for the United States Postal Service.

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