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Bob (oh, THAT Bob)
09-02-2009, 03:01 PM
I've mentioned this subject before with regard to doctors handing out pills like candy mints (especially anti-depressants) when they are not indicated by the symptoms. ("off-label") The following article is proof of doctors being bribed to do so.


http://l.yimg.com/a/i/us/fi/gr/ap_106x27.gif (http://us.rd.yahoo.com/finance/news/apf/SIG=10kfmofol/*http://www.ap.org/) Pfizer to pay record $2.3B penalty over promotions

Pfizer paying record $2.3B settlement for illegal promotions of 4 prescription drugs



By Devlin Barrett, Associated Press Writer
On Wednesday September 2, 2009, 2:57 pm EDT

WASHINGTON (AP) -- Pfizer Inc., the world's largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions.



Announcing the settlement Wednesday, the Justice Department said that it included the largest criminal fine in U.S. history -- $1.2 billion. The agreement also included a criminal forfeiture of $105 million.
Authorities called Pfizer a repeat offender, noting it is the fourth such settlement of government charges in the last decade. They said the government will monitor the company's conduct for the next five years to rein in the abuses.


To promote the drugs, authorities said Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks.


"They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. attorney in Massachusetts.


Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.


Six corporate whisteblowers who first brought the misconduct to light will share $102 million of the settlement money.


FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to "speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims."


Associate Attorney General Thomas Perelli said the settlement illustrates ways the department "can help the American public at a time when budgets are tight and health care costs are rising."
The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.


The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved for by federal regulators.


Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration.


Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market in 2005 amid mounting evidence it raised the risk of heart attack, stroke and death.


A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.


The $1 billion in civil penalties was related to Bextra and a number of other medicines. A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state's Medicaid program.


"These agreements bring final closure to significant legal matters and help to enhance our focus on what we do best -- discovering, developing and delivering innovative medicines to treat patients dealing with some of the world's most debilitating diseases," said Amy W. Schulman, senior vice president and general counsel of Pfizer.


Justice officials discussed details of the deal at a news conference with FBI, federal prosecutors, and Health and Human Services Department officials.


In financial filings in January, the company had indicated that it would pay $2.3 billion over allegations it had marketed the pain reliever Bextra and possibly other drugs for medical conditions different than their approved use. The civil settlement announced Wednesday also covered Pfizer's promotions of three other drugs: blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Pfizer said the agreement with the Justice Department resolves the investigation into promotion of all those drugs, plus several related whistleblower lawsuits.


Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state's attorney general, Andrew Cuomo.


"Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line," Cuomo said. "Pfizer's corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company's drugs for patients in taxpayer-funded programs."
Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion charge to the company's earnings had been taken in the fourth quarter of 2008.


"No additional charge to the company's earnings will be recorded in connection with this settlement," he said.


In her statement, Schulman said: "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health."
"Corporate integrity is an absolute priority for Pfizer," she said, "and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company."
When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer's position as the world's top drug maker by revenue, is expected to close before year's end.


Shares of Pfizer dropped 14 cents to $16.24 in midday trading.
AP Business Writer Linda A. Johnson in Trenton, N.J. contributed to this report.

Captain Intrepid
09-02-2009, 03:07 PM
Go free market go! Go free market go! Go free market go! YEAH FREE MARKET!

Socialism sucks!

htom
09-02-2009, 03:32 PM
And on the other hand, they're prosecuted for underprescribing, if the doctor is unwilling to write a script for the patient need, which is higher than the DEA thinks it "should" be.

paladin
09-02-2009, 03:50 PM
I was burned by an idiot doctor over that last year. After surgery I went in for a follow up appointment with my arm red after surgery. The regular doctor wasn't there and I saw the temp....and he decided my arm was infected.....I said "no, I have a reaction to the meds they were using"...he strongly insisted that I was mistaken and he was the doctor and he was prescribing Zyvox.....at the pharmacy checkout I discovered that I received 14 tabs at a cost of 999.30. My insurance paid the most of it, but it went against my annual $3500 budget. I was livid and complained about it to my doctor. No avail...they just paid it.

Andrew Craig-Bennett
09-02-2009, 04:01 PM
Well, you have your free market, and we, with our evil gummint socialist system, have these NICE people, to keep that sort of thing in check:

http://www.nice.org.uk/

Which, along with no insurance bureaucracy, no profits for insurance companies and few malpractice suits, is why our system costs so much less than yours for better overall results.

JBreeze
09-02-2009, 04:27 PM
Just a couple of comments:

1) Doctors using a drug for an indication for which it hasn't been approved.(off-label use)

This happens more frequently than you might think. It is very expensive to perform the clinical trials in order to receive the FDA's approval for a disease or condition. If a drug is approved, a doctor is allowed to use it for any indication he/she sees fit.

An example....back when I worked in a hospital, methotrexate was approved for things like some cancers, rheumatoid arthritis and psoriasis. The drug is relatively benign, compared to some of the alkylating agent chemotherapeutic drugs.

My institution used it frequently - for fallopian tube pregnancies. A tubal pregnancy is a potentially life threatening event for the mother, and the surgery to terminate this type of prenancy is expensive and sometimes causes the mother to become less fertile. The best solution was 50 mg of methotraxate im x 1 dose. This terminated the fallopian tube pregnancy, was comfortable for the mother, and minimized the risk of infertility, while avoiding the pain and expense of surgery. This is just one example of using an approved drug for an unapproved indication, and is legal. So don't over-react about using drugs for unapproved purposes.

2)Paladin's situation

It is hard to make a judgement about this, because I wasn't there...my guess is the doctor didn't know the patient and his history, and weighed the risks of allowing a potential drug resistant infection to progress, vs treating an allergic reaction. Risk vs reward. Not sure what i would have recommended, especially if Paladin came in wearing his sidearm;)

3) Spreading the money around.....yep, drug companies used to blow all sorts of money of social activities.....it changed to "educational" activities, often at fancy hotels, restaurants, golf courses, etc. Same for the medical device manufacturers. It's somewhat different now, but still exists. I expect someone to reply to this thread and state that he doesn't see it. If so, I'll find the links to the internet drug rep. gossip board, and you can read about what companies like Astra used to do. One of the major drug companies Wyeth(?) has a web site that lists all payments to physicians.....most of the money is spent, in reasonable amounts, for "professional" education, rather than patient education. Draw your own conclusions.

Summary - I wanted to draw your attention to "unapproved uses"....often this is a red herring and the unapproved use is legitimate

Gonzalo
09-02-2009, 04:53 PM
What do you want to bet that those executives responsible for breaking the law and costing the stockholders $2.3 billion will not be fired, but will receive big bonuses for "risk taking?"

Free market advocates can further their case by firing executives guilty of malfeasance, but my guess is they will not, thus proving once again that executive compensation is not governed by the free market, but by cronyism.

Post here about the firings to prove me wrong.

George Jung
09-02-2009, 06:29 PM
Medicine was the whipping boy for the past ten or so years, and now big pharma is in the crosshairs. Some of the criticism is legitimate, some of it is just bashing. But I have no doubt that Obama intends to markedly 'constrict' these companies, and I expect their revenues, and company size, is about to take a hit. I've noticed at least one major story in the news the past several days. Two days ago, Forest was criticized (front page, NYT) for over-promoting Lexapro, an antidepressant. According to the article, this was at the behest of the Obama White House (I didn't know the White House was responsible for that). Today, the story about Pfizer. My suspicion is, it's an orchestrated effort to promote more use of generics, and curtail any influence Big Pharma might have in marketing their products. Not necessarily a bad thing, btw - but the methods leave me a feeling a touch chilled. I'll be watching closely, to see if this trend continues.

George Jung
09-02-2009, 09:26 PM
Yer a funny guy, bobbys...