Department of Justice files amicus brief supporting Rost in United States ex. rel. Peter Rost v. Pfizer et al. 03-CV-11084

DOJ Amicus Brief

Health-care bill wouldn't bring real reform

By Howard Dean
Thursday, December 17, 2009
Washington Post

If I were a senator, I would not vote for the current health-care bill. Any measure that expands private insurers' monopoly over health care and transfers millions of taxpayer dollars to private corporations is not real health-care reform. Real reform would insert competition into insurance markets, force insurers to cut unnecessary administrative expenses and spend health-care dollars caring for people. Real reform would significantly lower costs, improve the delivery of health care and give all Americans a meaningful choice of coverage. The current Senate bill accomplishes none of these.

Real health-care reform is supposed to eliminate discrimination based on preexisting conditions. But the legislation allows insurance companies to charge older Americans up to three times as much as younger Americans, pricing them out of coverage. The bill was supposed to give Americans choices about what kind of system they wanted to enroll in. Instead, it fines Americans if they do not sign up with an insurance company, which may take up to 30 percent of your premium dollars and spend it on CEO salaries -- in the range of $20 million a year -- and on return on equity for the company's shareholders. Few Americans will see any benefit until 2014, by which time premiums are likely to have doubled. In short, the winners in this bill are insurance companies; the American taxpayer is about to be fleeced with a bailout in a situation that dwarfs even what happened at AIG.

From the very beginning of this debate, progressives have argued that a public option or a Medicare buy-in would restore competition and hold the private health insurance industry accountable. Progressives understood that a public plan would give Americans real choices about what kind of system they wanted to be in and how they wanted to spend their money. Yet Washington has decided, once again, that the American people cannot be trusted to choose for themselves. Your money goes to insurers, whether or not you want it to.

To be clear, I'm not giving up on health-care reform. The legislation does have some good points, such as expanding Medicaid and permanently increasing the federal government's contribution to it. It invests critical dollars in public health, wellness and prevention programs; extends the life of the Medicare trust fund; and allows young Americans to stay on their parents' health-care plans until they turn 27. Small businesses struggling with rising health-care costs will receive a tax credit, and primary-care physicians will see increases in their Medicare and Medicaid reimbursement rates.

Improvements can still be made in the Senate, and I hope that Senate Democrats will work on this bill as it moves to conference. If lawmakers are interested in ensuring that government affordability credits are spent on health-care benefits rather than insurers' salaries, they need to require state-based exchanges, which act as prudent purchasers and select only the most efficient insurers. Sen. John Kerry (D-Mass.) offered this amendment during the Finance Committee markup, and Democrats should include it in the final legislation. A stripped-down version of the current bill that included these provisions would be worth passing.

In Washington, when major bills near final passage, an inside-the-Beltway mentality takes hold. Any bill becomes a victory. Clear thinking is thrown out the window for political calculus. In the heat of battle, decisions are being made that set an irreversible course for how future health reform is done. The result is legislation that has been crafted to get votes, not to reform health care.

I have worked for health-care reform all my political life. In my home state of Vermont, we have accomplished universal health care for children younger than 18 and real insurance reform -- which not only bans discrimination against preexisting conditions but also prevents insurers from charging outrageous sums for policies as a way of keeping out high-risk people. I know health reform when I see it, and there isn't much left in the Senate bill. I reluctantly conclude that, as it stands, this bill would do more harm than good to the future of America.

The writer is a former chairman of the Democratic National Committee and was governor of Vermont from 1991 to 2002.

Religion 101: Final Exam (I'd love comments on this one!)

by Terrence Kaye

The author gratefully acknowledges the inspiration provided by E.T. Babinski, Dan Barker, George Carlin, Richard Dawkins,, Sam Harris, Judith Hayes, James Haught, Robert Ingersoll, Adam Lee, John Stuart Mill, Pablo Neruda, Blaise Pascal, Seneca, Julia Sweeney, Jethro Tull, Mark Twain, and Mark Vuletic.

1. Which of the following is the most compelling evidence for the existence of an intelligent and loving Designer?
   
   
   
   
   
   1. The little girl born in Egypt with two functioning heads
   
   
   2. The screams of a baby seal as it is torn apart by a shark
   
   
   3. The superiority of the octopus eyeball to the human
   
   
   4. A Caribbean sunset
   
   
   
   
   
   



2. A Christian couple has just returned from their fiftieth anniversary celebration, when suddenly the husband falls to the ground, clutching his chest. Assuming the morally proper action is to try to save his life, what is the most morally proper action the wife could take?
   
   
   
   
   
   1. Call 911
   
   
   2. Put him in the car and race to the hospital herself
   
   
   3. Administer CPR
   
   
   4. Fall on her knees and pray to the Lord to spare his life
   
   
   
   
   
   



3. You are a product tester and frequently bring your work home. Yesterday, while dressed in a flame-resistant suit (up to 3,000 degrees) and carrying the latest model fire extinguisher, you discovered your neighbor's house on fire. As the flames quickly spread, you stood by and watched the family perish. Which of the following best describes your behavior?
   
   
   
   
   
   1. All-powerful
   
   
   2. All-knowing
   
   
   3. All-loving
   
   
   4. Mysterious
   
   
   
   
   
   



4. One day while jogging in the park, you see a maniac with a butcher knife about to attack a six-year old girl. What should you do?
   
   
   
   
   
   1. Grab the nearest rock and club the attacker
   
   
   2. Call the police on your cell phone
   
   
   3. Yell "POLICE!" and run toward the attacker in a threatening manner
   
   
   4. Calmly walk away, because God works in mysterious ways, and what appears "evil" to our finite human mind, may in fact be part of a vaster plan in God's infinite mind, so it's best not to interfere
   
   
   
   
   
   



5. You are a loving family man who volunteers as a Big Brother and also at the local hospice when not working as the director of the community food bank. You awaken this morning to discover the global news media ablaze with the first-ever, easily understood, irrefutable scientific proof that there is no God. What will you probably do?
   
   
   
   
   
   1. Quit your job and become a full-time rapist
   
   
   2. Abandon your family and go on a murder rampage
   
   
   3. Become a professional burglar
   
   
   4. Continue your life pretty much as usual
   
   
   
   
   
   



6. Since we can never "know" whether or not a God exists - it is fundamentally a matter of "faith" - it's best to be a believer since you have nothing to lose, but everything to lose if your disbelief is incorrect. Keeping in mind that the fate of your soul depends on the right choice, in which God should you place your belief? For extra credit, include a brief essay justifying your choice, along with the reasons why you reject the other three.
   
   
   
   
   
   1. Zeus
   
   
   2. Odin
   
   
   3. Vishnu
   
   
   4. The Holy Trinity
   
   
   
   
   
   



7. You are the Creator of the universe. Your chosen people are a tribe of nomadic herdsmen, presently in bondage on one of the millions of your planets. Their ruler is being quite obstinate. Keeping in mind that you possess not only infinite power but also infinite love, your best course of action would be to:
   
   
   
   
   
   1. Cause the ruler to drop dead of a heart attack
   
   
   2. Cause the ruler to fall off a cliff
   
   
   3. Visit the ruler in a dream and persuade him to let your people go
   
   
   4. Slaughter a great number of innocent babies who had nothing to do with the ruler's policies
   
   
   
   
   
   



8. You are a Starfleet Federation explorer in the process of cataloging two newly discovered planets. The majority of the inhabitants of each planet believe in a deity, but they are two different deities. Deity "X" is said to be not only all-powerful, all-loving, and all-knowing, but the designer of a marvelously complex and ordered world. Deity "Y" is said to be indifferent, absent, unconcerned with the affairs of his planet, and some even say evil. Which god rules over which planet?
   
   
   
   Planet A: Has apparently achieved a state of advanced benign equilibrium in which there are no viruses or diseases, and only a very small number of natural disasters, which, when they do strike, always eliminate only the sinful and evil. The inhabitants, both plant and animal, have learned to maintain their existence through photosynthesis, and thus do not have to kill and eat each other in order to survive. There are no "birth defects"; every inhabitant comes into existence perfectly formed and equipped for a long and productive life.
   
   
   
   Deity X_____
   
   Deity Y_____
   
   
   
   Planet B: Adorned with many examples of beauty and order, it is also constantly beset by hurricanes, earthquakes, tsunamis, floods, volcanoes, lightning bolts, viruses, disfiguring diseases, parasites, leeches, flies, crop-destroying pests and many other phenomena which afflict both the innocent and the evil. Every life form on the planet can only sustain its existence through the destruction and consumption of other life forms. Some of the inhabitants are born with a crippling condition called a "birth defect" which condemns them to living extremely limited, short or painful lives.
   
   
   
   Deity X_____
   
   Deity Y_____
   
   
   
   



9. What is the number of children born without arms or legs that have been miraculously restored by a visit to the shrine at Lourdes, France?
   
   
   
   
   
   1. Too many to count
   
   
   2. Over 1,000
   
   
   3. Several dozen
   
   
   4. Zero, but only because their faith was not strong enough
   
   
   
   
   
   



10. As we all know, there is only one true religion. What is the one true religion in each of the following circumstances?
    
    
    
    
    
    1. You are born in Karnak in 3000 B.C.
    
    
    2. You are born in Bombay in 300 B.C.
    
    
    3. You are born in Baghdad in 900 A.D.
    
    
    4. You are born in Mexico City in 1956 A.D.
    
    
    
    
    
    



11. Although you are new at golf, you have just hit a beautiful 200-yard drive and your ball has landed on a blade of grass near the cup at Hole 3. The green contains ten million blades of grass. The odds of your ball landing on that blade of grass are 9,999,999 to one against, too improbable to have happened by mere chance. What's the explanation?
    
    
    
    
    
    1. The wind guided it
    
    
    2. Your muscles guided it
    
    
    3. There is no need for an explanation
    
    
    4. You consciously designed your shot to land on that particular blade
    
    
    
    
    
    



12. Which of the following is most likely to be true, and why?
    
    
    
    
    
    1. Romulus was the son of God, born to a mortal human virgin
    
    
    2. Dionysus turned water into wine
    
    
    3. Apollonius of Tyana raised a girl from the dead
    
    
    4. Jesus Christ was the son of God, born to a mortal virgin, turned water into wine, and raised a man from the dead
    
    
    
    
    
    



13. Conceding that torture is permissible under certain conditions, which of the following would be the best justification?
    
    
    
    
    
    1. Your prisoner is the only one who knows the date and time of an assassination attempt on the Pope
    
    
    2. Your prisoner is the only one who knows where a nuclear device has been planted in Washington, D.C.
    
    
    3. Your prisoner is the only one who knows where a vial of nerve gas has been placed in the London water supply system
    
    
    4. Your prisoner has announced that the earth revolves around the sun
    
    
    
    
    
    



14. We know that Christianity is true because the Gospel writers, inspired by God who can make no error, recorded the founding events. For example, on the first Easter morning, the visitors to the tomb were greeted by which of the following:
    
    
    
    
    
    1. A young man (Mark 16:5)
    
    
    2. No, no, it was no man, it was an angel (Matthew 28:2-5)
    
    
    3. You're both wrong, it was two men (Luke 24:4)
    
    
    4. Damn it, there was nobody there (John 20:1-2)
    
    
    
    
    
    



15. Only human beings have souls, and thus only human beings can go to heaven. What is the cutoff point for entry into paradise?
    
    
    
    
    
    1. Homo habilis
    
    
    2. Homo erectus
    
    
    3. Homo Neanderthalensis
    
    
    4. Homo sapiens
    
    
    
    
    
    



16. According to at least one sainted church father, one of the pleasures of the saved in paradise will be to behold the agony of the damned in hell. What would be the best time of day in heaven for a mother to behold the agony of her only son who didn't make it?
    
    
    
    
    
    1. Early in the morning before it gets too crowded
    
    
    2. Mid-day when she can compare notes and share the celebration with other mothers
    
    
    3. Late at night when she can enjoy the flames in starker contrast
    
    
    
    
    
    



17. In the Judeo-Christian tradition, we always look to the Bible as a guide. In this example, your teenage son has returned home from the prom intoxicated. If you want to follow the Bible, you should:
    
    
    
    
    
    1. Sit him down for a heart to heart talk
    
    
    2. Enroll him in AA
    
    
    3. Take away his driving privilege for one month
    
    
    4. Smash his head in with rocks
    
    
    
    
    
    



18. In this example, your son-in-law, returned from his honeymoon, has just told you he suspects your daughter was not a virgin on their wedding night. Wishing to abide by God's holy rules as laid out in the Bible, you should:
    
    
    
    
    
    1. Ask him if he was a virgin before you do anything
    
    
    2. Advise him to forgive her
    
    
    3. Talk to your daughter
    
    
    4. Go find those rocks
    
    
    
    
    
    



19. You are eating lunch at a crowded fast food restaurant, occupied mostly by children, when suddenly a gunman bursts in, screams "Do not question or test me," and sprays the room with bullets. Ten people are killed instantly, many more grievously wounded, but somehow you escape unharmed. His ammunition expended, the gunman heads for the door. What should you do?
    
    
    
    
    
    1. Call the police and wait for them to arrive
    
    
    2. Call the police and leave
    
    
    3. Risk death by asking the gunman why he did it, even though he told you not to
    
    
    4. Fall on your knees and give thanks and praise to the gunman for sparing your life
    
    
    
    
    
    



20. Why did God show his backside to Moses, as described in Holy Scripture, Ex.33:23?
    
    
    
    
    
    1. He invented everything, and this was simply the first mooning
    
    
    2. He was really ticked off when Moses dropped the tablets
    
    
    3. He was piqued, having just discovered His almighty powers were useless against chariots of iron (Judges 1:19)
    
    
    4. Moses was too serious and needed to lighten up a little
    
    
    
    
    
    



21. Jesus was God, and God knows all things, including all the medical knowledge that will ever be known. Why did Jesus blame demons for the case of epilepsy he cured?
    
    
    
    
    
    1. He was suffering from a temporary case of "brain freeze"
    
    
    2. The Aramaic word for "demon" is the same as the word for "cranial malfunction"
    
    
    3. Neurology was not his specialty
    
    
    4. In first-century Palestine, demons really did cause epilepsy. This affliction only began to be caused by electrochemical brain activity after about 1850 A.D.
    
    
    
    
    
    



22. Today's paper carries a story about a suburban father who became so enraged with his disobedient children that he carried all nine of them to the backyard pool where he drowned them, along with their puppies, their kittens, and their hamsters. How should this father be treated?
    
    
    
    
    
    1. He should be prosecuted to the fullest extent of the law
    
    
    2. He should be banished from the town
    
    
    3. He should be lynched to save the taxpayers' money
    
    
    4. The townspeople should gather together to sing hymns of praise to him
    
    
    
    
    
    



23. This morning I started my day by insulting my mother in public, then punched out my father, my brother, and my sister. Then I gathered up all my clothes, sold them to a second-hand store, and with the proceeds bought a used assault rifle and 50 rounds of ammunition. Next, I went down to the animal shelter and injected all the dogs with a drug that caused them to go insane and dive into the nearby canal where they all drowned. By this time I was hungry, so I went over to my neighbor's apple orchard and burned it down, because I wanted an orange and there weren't any. On the way home, I stopped at the local steel mill to discuss my philosophy of life with some of the guys. They laughed at me and said to stow it, so I tossed them all into the blast furnace. That night I discovered my son looking at a copy of Playboy. Concerned for his future welfare, I cut off his right hand. What historical character did my activities today most resemble?
    
    
    
    
    
    1. Genghis Khan
    
    
    2. Charles Manson
    
    
    3. Adolph Hitler
    
    
    4. Jesus Christ
    
    
    
    
    
    



24. Down through the ages, who has been most responsible for the medical discoveries that have relieved untold amounts of suffering and pain, and extended the length of that most sacred of creations, the only species made in the divine image, human life?
    
    
    
    
    
    1. Medical doctors
    
    
    2. Research biologists
    
    
    3. Chemists
    
    
    4. The Catholic Church
    
    
    
    
    
    



25. A great sadness has come into your life which you feel you cannot bear. A friend informs you of a free counseling service which has never failed to aid and comfort many others. You call the counselor; the phone rings and rings with no answer; you finally hang up. What is the most likely explanation?
    
    
    
    
    
    1. The counselor is sitting by the phone but not answering in order to test your faith in him
    
    
    2. The counselor is fully qualified and able to help you, but just doesn't feel like it right now
    
    
    3. The counselor will not answer because he wants you to profit by the spiritual strength that only comes through suffering
    
    
    4. The counselor is not home
    
    
    
    
    
    




26. ESSAY QUESTION
    
    While it is true that there have been and still are many different gods and many different religions, they are really just different names by which various cultures approach the same God. Explain how and why each of the following is the same God:
    
    
    
    
    
    • Quetzalcoatl, who wants you to skin a young virgin alive, then put on the skin and dance;
    
    
    • Shiva, who wants you to pray over his penis;
    
    
    • Allah, who wants you to fly airliners into buildings;
    
    
    • Catholic God, who speaks directly through the Pope;
    
    
    • Hebrew God, who most definitely does not;
    
    
    • Jesus, who wants you to castrate yourself to ensure arrival in heaven
    
    
    • Jehovah, who any day now, is going to kill everyone on the earth except for his Witnesses
    
    

Make my dreams come true . . .

Japanese blogs are starting to write about The Whistleblower / 製薬業界の闇

Here's one example:

きのう買った本がベラボーに面白い。 Bella Bo interesting books I bought yesterday.
『製薬業界の闇』というタイトルで、副題は「世界最大の製薬会社ファイザーの正体」とある。 』By『 darkness of the pharmaceutical industry titled subtitle is "the identity of the world's largest pharmaceutical company Pfizer," the term. 著者はファイザー社の元マーケティング部長のピーター・ロスト氏。 The author's former marketing chief Peter Lost Pfizer.
この本、よく出来た推理小説を読んでるかのごとく面白くて、 This book, as if I'm reading an interesting and well constructed thriller, きのう読み始めたんだけど、途中で止められなくて困っている。 I started reading yesterday, are in trouble because I could not stop in the middle.

著者が本の中で素晴らしい！ Author in the book great!

Sales success in Japan for The Whistleblower, Confessions of a Healthcare Hitman!

The Whistleblower, Confessions of a Healthcare Hitman appears to be doing great in Japan.

The book is right now #153 among hardcover books, and 382 overall!

:))



Or, as it is called in Japan:
製薬業界の闇 (単行本)
ピーター・ ロスト (著), 斉尾 武郎 (監修)

This literally translates into "Pharmaceutical Industry Darkness."

Go to Amazon Japan to buy! The book was released December 11.

Here's a Google translation from the publisher's web site:

Drug reimportation redux: Now the dems don't want to offend Big Pharma.

WASHINGTON — Debating an overhaul of the health care system, the Senate found itself tied in knots on Thursday over a bipartisan proposal to allow people to import lower-cost prescription drugs from Canada and certain other countries.

The chief sponsor of the proposal, Senator Byron L. Dorgan, Democrat of North Dakota, said: “People are walking on eggshells. If we pass legislation allowing people freedom to import drugs, the pharmaceutical industry might not support the health care bill.”

Senator John McCain, Republican of Arizona, a leading proponent of drug imports, said, “There’s great dissension in the Democrat caucus over Senator Dorgan’s amendment concerning importation of drugs from Canada and other countries.”

“If it passes, as it should, it breaks the agreement that the White House made with PhRMA,” Mr. McCain said. “So the White House, as well as PhRMA, has been over here lobbying furiously.”

In a letter to the Senate, Dr. Margaret A. Hamburg, the commissioner of food and drugs, expressed concern that imported drugs might be contaminated or counterfeit because the Food and Drug Administration “does not have clear authority over foreign supply chains.”

The Congressional Budget Office estimated that Mr. Dorgan’s amendment would save the federal government $19.4 billion over the next decade, because federal programs would spend less on medications.

“U.S. consumers are charged the highest prices in the world for drugs that sell for a fraction of the price in most other countries,” Mr. Dorgan said. “My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk. It applies only to F.D.A.-approved prescription drugs produced in F.D.A.-approved plants from countries with comparable safety standards.”

New York Times

I loved this video. Find out why.

The Whistleblower, Confessions of a Healthcare Hitman now available in Japan!

Or, as it is called in Japan:
製薬業界の闇 (単行本)
ピーター・ ロスト (著), 斉尾 武郎 (監修)

This literally translates into "Pharmaceutical Industry Darkness."

Go to Amazon Japan to buy! The book will be released December 11.


Here's a Google translation from the publisher's web site:

Tiger Woods Slow Jam Video is Sad and Funny at the same time.

And it already has over a million hits . . .

"I'm great in bed, I make great money, I'm a complete catch, but if you don't call me by 3 Thursday afternoon you can erase my number"

One more reason women don't call men back?

One night at a San Francisco Marina a woman named Olga spoke to a man who called himself Dimitri for about 2 minutes, then she gave him her business card with her phone number on it and said "call me." Dimitri then left the follow two crazy messages:

Girls with cigarettes.

Candy Cigarette by Sally Mann (Conscientious)


Unknown.

I felt bad for the IKEA lamp.

Guess this pic could set off a few family brawls.

The Swiss voted to ban new Minarets. Here's the reason Muslim countries forbid other religions to build places of worship.

Follow me!

Most amazing music video ever made.

Amazing video of San Francisco street life in 1905

What the people who love Sarah Palin are saying . . . don't miss!

In support of free speech: Meep!

And if you care, you should meep too.

Read the amazing story about the school principal who tried to ban a word.

$0.99 Kindle edition of "Killer Drug" increases sales dramatically.

Get your digital copy sent to your iPod, iPhone or Kindle here:

Here's some perspective on the stock market . . .

Our generation . . .

Too skinny? This apparently used to be a problem . . .

Pfizer Broke the Law by Promoting Drugs for Unapproved Uses

By David Evans

Nov. 9 (Bloomberg) -- Prosecutor Michael Loucks remembers clearly when lawyers for Pfizer Inc., the world’s largest drug company, looked across the table and promised it wouldn’t break the law again.

It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.

In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.

New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.

What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off-label marketing even before the ink was dry on their plea.

On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.

Record High Fine

For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the U.S. and 49 states.

“At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws,” Loucks, 54, says. “They’ve repeatedly marketed drugs for things they knew they couldn’t demonstrate efficacy for. That’s clearly criminal.”

The penalties Pfizer paid this year for promoting Bextra off-label were the latest chapter in the drug’s benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.

Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death.

$7 Billion in Penalties

Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses.

In September 2007, New York-based Bristol-Myers paid $515 million -- without admitting or denying wrongdoing -- to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.

In January 2009, Indianapolis-based Lilly, the largest U.S. psychiatric drug maker, pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had for at least four years illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia, as a remedy for dementia in elderly patients.

In five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking the drug for dementia -- twice the death rate for those taking a placebo. Those findings were reported in an October 2005 article in the Journal of the American Medical Association.

‘Don’t Respect the Law’

“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law,” says Jerry Avorn, a professor at Harvard Medical School in Boston and author of “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs” (Random House, 2004). “The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.”

The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.

“It’s an unbearable cost to a system that’s going broke,” says Avorn, who heads the pharmacology economics unit of Brigham and Women’s Hospital in Boston. “We can’t even afford to pay for effective, safe therapies.”

10 Million Prescriptions

About 15 percent of all drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work, according to a study by Randall Stafford, a medical professor at Stanford University in Palo Alto, California.

He estimates that doctors write more than 10 million such prescriptions each year.

As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms’ annual revenues.

The $2.3 billion in fines and penalties Pfizer paid for marketing Bextra and three other drugs cited in the Sept. 2 plea agreement for off-label uses amount to just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.

The total of $2.75 billion Pfizer has paid in off-label penalties since 2004 is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.

$36 Billion in Revenue

Lilly already had a criminal conviction for misbranding a drug when it broke the law again in promoting schizophrenia drug Zyprexa for off-label uses starting in 1999. The medication provided Lilly with $36 billion in revenue from 2000 to 2008.

That’s more than 25 times as much as the total penalties Lilly paid in January.

Companies regard the risk of multimillion-dollar penalties as just another cost of doing business, says Lon Schneider, a professor at the University of Southern California’s Keck School of Medicine in Los Angeles.

In 2006, he led a study for the National Institute of Mental Health of off-label use of drugs, including Zyprexa, for the treatment of Alzheimer’s disease.

“There’s an unwritten business plan,” he says. “They’re drivers that knowingly speed. If stopped, they pay the fine, and then they do it again.”

Shareholders Unmoved

Schneider has been paid both by Lilly as a consultant and by plaintiffs suing the company.

Big Pharma’s off-label transgressions didn’t trigger a rush for the doors by shareholders. From Jan. 26, when Pfizer announced that it would pay billions in penalties, to Oct. 12, Pfizer’s share price increased 9.3 percent, just shy of the 11.2 percent rise in the Standard & Poor’s 500 Health Care Index.

From Oct. 21, 2008, when Lilly said it would pay its penalties, to Oct. 12, the company’s stock value went up 0.6 percent; the S&P index gained 6.9 percent in that time.

In pushing off-label use of drugs, companies find ready and willing partners in physicians. Under the fragmented system of medical regulation in the U.S., it’s legal for doctors to prescribe FDA-approved drugs for any use.

The FDA has no authority over doctors, only over drug companies, regarding off-label practices. It’s up to the 50 states to oversee physicians.

“I think the physician community has to take some ownership responsibility and do their own due diligence beyond the sales and marketing person,” says Boston’s former U.S. Attorney Michael Sullivan.

Off-Label Benefits

Loucks says prosecutors realize that patients can benefit when doctors use drugs for off-label purposes based on science and not on false marketing claims.

Doctors generally don’t tell people that they’re prescribing drugs pitched to them by pharmaceutical salespeople for unapproved treatments, says Peter Lurie, deputy medical director of Public Citizen, a Washington-based public interest group.

Most physicians don’t keep track of FDA-approved uses of drugs, says Lurie, a physician who has published articles in “The Lancet” and the “Journal of the American Medical Association.”

“The great majority of doctors have no idea; they don’t even understand the distinction between on- and off-labeling,” Lurie says.

Pharmaceutical companies have showered doctors with cash to persuade them to use drugs off-label, according to their guilty pleas.

‘Buying Access’

Pfizer’s marketing program offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients, according to a whistle-blower lawsuit filed by John Kopchinski, who worked as a salesman at Pfizer from 1992 to 2003.

“By ‘pairing up’ with a physician, the sales representative was able to promote over a period of many hours, without the usual problems of gaining access to prescribing physicians,” Kopchinski says. “In essence, this amounted to Pfizer buying access to physicians.”

Pfizer spokesman Chris Loder says the company stopped what it calls “mentorships” in 2005. He says Pfizer paid doctors $250 per visit.

It used to be legal for companies to promote drugs for any use in the U.S. Congress banned the practice in 1962. The catalyst was Thalidomide, a morning sickness drug taken by pregnant women outside the U.S. that caused severe birth defects.

Recouping Investments

The 1962 law required pharmaceutical companies to prove their drugs were safe and effective for specific uses. Before that, a drug company could market an approved medicine for any illness.

If the law is clear, why do drug companies keep breaking it? The answer lies in economics. Pharmaceutical companies spend about $1 billion to develop and test a new drug. To recoup their investment, the companies want doctors to prescribe their drugs as widely as possible.

Pfizer’s Neurontin is a case in point. The FDA approved the drug as a supplemental medication in treating epilepsy in 1993. Pfizer took in $2.27 billion from sales of Neurontin in 2002. A full 94 percent -- $2.12 billion -- of that revenue came from off-label use, according to the prosecutors’ 2004 Pfizer sentencing memo.

Pfizer, which bought Wyeth on Oct. 15 for $68 billion, put itself at the center of illegal off-label drug marketing with an acquisition frenzy a decade earlier. From 1995 to 2005, Pfizer purchased more than 20 companies.

Guilty Pleas

Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to Pfizer’s Sept. 2 guilty plea and FDA correspondence with Pfizer.

Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Morris Plains, New Jersey-based Warner-Lambert Co. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999.

Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for which Pfizer paid $430 million in fines and penalties.

Neurontin, which was invented by Warner-Lambert, was first tested in humans in 1987. When the FDA approved it in 1993 to be used only along with other epilepsy drugs, the agency wrote that a side effect of the drug can be that it induces depression and suicidal thoughts in patients.

Whistle-Blower

Much of what prosecutors learned about Warner-Lambert’s marketing of Neurontin comes from a former employee.

David Franklin, who holds a Ph.D. in microbiology from the University of Rhode Island, left his job as a pediatric researcher at Harvard University’s Dana-Farber Cancer Institute in 1996 to work for the Parke-Davis unit of Warner-Lambert in Boston.

He says he hoped the salary boost -- to $55,000 annually from $18,000 -- would help him pay off student loans and better support his family.

Franklin’s title at Warner-Lambert was medical liaison. He says he soon realized his new employer viewed his doctorate as a badge that would allow him to strike up conversations with physicians.

Franklin, 48, says his job involved more salesmanship than science. He told doctors that Neurontin was the best drug for a dozen off-label uses, including pain relief, bipolar disease and depression.

‘What I Did Was Wrong’

“Technically, I had responsibility for answering physician questions about all of Parke-Davis’s drugs,” Franklin says. “In practice, my real job was to promote Neurontin for off- label indications heavily -- to the exclusion of just about everything else.”

Franklin, whose wife is a lawyer, says he knew such uses of the drug had no scientific support for effectiveness and safety.

“I was actually undermining their ability to fulfill the Hippocratic oath,” Franklin says, referring to a physician’s pledge to “first, do no harm.”

Franklin says he was horrified when he learned from a doctor that a child had a behavioral outburst at school for the first time after taking Neurontin.

“Don’t we have an obligation to tell physicians about this?” Franklin says he asked his manager, Phil Magistro. His boss tried to reassure him, Franklin says.

‘Total Disregard’

“‘Don’t worry about this stuff,’” he says Magistro told him. “‘It can never get back to us.’”

Franklin was stunned.

“I realized at that moment, looking into his eyes, that there was an absolute total disregard for the patient,” he says.

Magistro, who now works at drug marketing adviser Atom Strategic Consulting LLC in Randolph, New Jersey, didn’t return calls seeking comment.

Franklin saved phone messages from Magistro to his sales team urging them to market Neurontin for off-label uses, including pain relief. During one such call, on May 23, 1996, at 5:48 p.m. in Boston, Magistro told his staff, “You’re supposed to be pushing on Neurontin,” according to a transcript of the tape filed in federal court.

“When we get out there, we want to kick some ass. We want to sell Neurontin on pain,” Magistro said. “All right?”

Quit the Job

After working for Warner-Lambert for three months, Franklin grew concerned about his own liability. He quit the job and talked with Boston attorney Thomas Greene, who helped him file a lawsuit against the company.

Franklin acted as a whistle-blower, suing on behalf of taxpayers to recover money the government paid for illegally promoted drugs. Under federal and state whistle-blower statutes, he stood to collect as much as 30 percent of any settlement the company made with the government.

Franklin had to wait four years -- until 2000 -- before the Justice Department began a criminal investigation. In November 1999, Pfizer made its public offer to buy Warner-Lambert. In January 2000, a federal grand jury in Boston issued subpoenas to Warner-Lambert employees to testify about the marketing of Neurontin.

That March, Warner-Lambert’s annual report disclosed that prosecutors were building a criminal case. Undeterred, Pfizer bought Warner-Lambert in June for $87 billion. It was the third- largest merger in U.S. history.

‘Misleading and in Violation’

A year after the acquisition, the FDA discovered that Neurontin was still being marketed off-label. In a letter to the company on June 29, 2001, the agency wrote that Pfizer’s promotion of the drug “is misleading and in violation of the Federal Food, Drug and Cosmetics Act.”

The agency asked Pfizer to stop such promotions of Neurontin. The FDA said Pfizer had distributed brochures -- known as “slim jims” because they’re small enough to put in a jacket pocket -- improperly claiming that the drug could improve energy levels and memory.

“Immediately discontinue the use of this slim jim and any other promotional material or practices with the same or similar messages,” the FDA wrote.

Pfizer marketed Neurontin off-label after receiving that letter, agency records show. For 2001, Pfizer reported revenue of $1.75 billion from Neurontin sales, making it the company’s fourth-largest-selling drug that year, ahead of impotence pill Viagra, which Neurontin topped for four years.

Marketing Violated Rules

As Neurontin sales soared to $2.27 billion in 2002, the FDA found that Pfizer was improperly claiming that the drug was useful for a broader range of brain disorders than scientific evidence had established.

The agency sent a letter dated July 1, 2002, that said the company’s marketing practices were in violation of FDA rules. It asked Pfizer to stop using misleading promotions. Pfizer reported $2.7 billion in revenue from Neurontin in 2003. Overall, the drug has provided Pfizer with $12 billion in revenue.

In a response to Bloomberg News, Pfizer spokesman Chris Loder said, “Regarding the 2001 and 2002 FDA letters, we do not believe that they were suggestive of any continuing off-label promotion.”

For blowing the whistle on his employer, Franklin collected $24.6 million under the False Claims Act.

Prosecutors Loucks and Sullivan got involved in the case after Franklin filed his suit, relying on information from Franklin and their own investigation. Before 2004, prosecutions for off-label marketing were rare.

‘Everybody Does It’

“Until a couple of these cases became public, companies were probably saying, ‘Everybody does it this way,’” Sullivan says.

Loucks had a track record in off-label prosecutions. He gave up private practice at Choate Hall & Stewart LLP in Boston in 1985 to join the U.S. Attorney’s Office.

In 1994, he negotiated a $61 million settlement with Murray Hill, New Jersey-based C.R. Bard Inc., which pleaded guilty to promoting off-label use of a heart catheter that led to patient deaths.

In 2002, he co-authored, with Carol Lam, “Prosecuting and Defending Health Care Fraud Cases” (BNA Books).

In the January 2004 settlement negotiations with Loucks, Sullivan and two other prosecutors, Pfizer’s lawyers assured the U.S. Attorney’s Office that the company wouldn’t market drugs off-label.

‘Those Promises’

“They asserted that the company understood the rules and had taken steps to assure corporate compliance with the law,” Loucks says. “We remember those promises.”

What Pfizer’s lawyers didn’t tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 of its salespeople. They were pitching Bextra, a Pfizer sales manager admitted when she pleaded guilty to misbranding a drug on March 30, 2009.

Jeff Kindler, who became Pfizer’s general counsel in 2002, supervised the lawyers who made the promises to prosecutors. By 2004, Kindler increased the compliance budget 12-fold. He became chief executive officer in 2006. In Pfizer’s ethics guide, he says stories about misbehaving companies and executives abound.

“Pfizer truly stands apart,” he says. “I am proud of our record.” On Oct. 1, Kindler was elected to the board of the Federal Reserve Bank of New York. Kindler declined to comment.

Peapack, New Jersey-based Pharmacia & Upjohn Inc. developed Bextra, which was approved by the FDA only for the treatment of arthritis and menstrual discomfort in 2001.

Sales Manager Pleads Guilty

P&U and Pfizer had by then already crafted a joint marketing agreement to sell the drug. In November 2001, Mary Holloway, a Pfizer regional manager for the Northeastern U.S., began illegally training and directing her sales team to market Bextra for the relief of acute pain, Holloway admitted in a March 2009 guilty plea.

On Dec. 4, 2001, Pfizer executives sent Holloway a copy of a nonpublic letter from the FDA to the company. The agency had denied Pfizer’s application to market Bextra for acute pain. Clinical trials had shown Bextra could cause heart damage and death.

Pfizer bought Pharmacia & Upjohn in April 2003. From 2001 to the end of 2003, P&U, first as an independent company and then as a unit of Pfizer, paid physicians more than $5 million in cash to lure them to resorts, where salespeople illegally pitched off-label uses for Bextra, P&U admitted in its Sept. 2 guilty plea.

‘Golf, Massages’

“Pharmacia paid targeted physicians both airfare and two to three days’ accommodations at lavish resorts in the Bahamas, Virgin Islands and across the United States and further entertained these physicians with golf, massages and other recreation activities,” according to prosecutors’ findings.

In her guilty plea, Holloway said her team had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn’t mention the increased risk of heart attacks in their marketing.

They told doctors that side effects were no worse than those of a sugar pill, Holloway admitted in her guilty plea.

In 2003, Holloway reported her unit’s off-label promotions of Bextra up the corporate ladder at Pfizer, according to a pre- sentencing memo to the judge written by Robert Ullmann, Holloway’s attorney. Top managers didn’t attempt to halt the illegal conduct, the memo said.

“Corporate tracked this information, and at no time did it inform Ms. Holloway that any of the reported protocols were inappropriate,” he wrote. “Instead, the instruction was to get more protocols.”

Blockbuster Status

By the end of 2004, Bextra reached blockbuster status, with annual sales of $1.29 billion. Holloway promoted Bextra until the FDA asked Pfizer in April 2005 to pull it from the market for all uses, evidence in her case shows.

The agency concluded that the drug increased the risk of heart attacks, chest infections and strokes in cardiac surgery patients. In June 2009, Holloway, 47, was sentenced to two years on probation and fined $75,000. She didn’t return phone calls seeking comment.

Ronald Rainero, a Pfizer district sales manager and employee for more than 20 years, says he was responsible for promoting Bextra in New York from 2001 to 2005. In September 2007, Rainero, 47, began cooperating with federal prosecutors on the Bextra case.

Hotel Meetings

He says he met monthly with his fellow managers at a Hilton hotel in Staten Island, New York, to discuss sales methods of promoting Bextra off-label. As a whistle-blower, Rainero was awarded $9.3 million as part of the September settlement.

In the same time period that Pfizer was marketing Bextra off-label, the company’s sales force was promoting another drug, Zyvox, improperly, Pfizer admitted at the time of its September plea agreement.

Zyvox was approved in 2000 by the FDA for treating MRSA- caused pneumonia and skin infections. Raniero told federal prosecutors that Pfizer began the Zyvox campaign in 2001. The company admitted to falsely claiming that the drug was better than other medications for treating MRSA pneumonia.

Pfizer told doctors to use Zyvox rather than vancomycin, a generic antibiotic that cost $18 a day. Pfizer sold Zyvox for about $150 a day. A table on page 30 of a 35-page fact book produced by Pfizer for Zyvox says the drug is less effective than vancomycin for MRSA pneumonia.

‘Misleading Promotion’

On July 20, 2005, the FDA sent a letter to Hank McKinnell, then Pfizer’s CEO, saying, “Your misleading promotion of Zyvox, and in particular your unsubstantiated implied claims regarding its superiority to vancomycin, poses serious health and safety concerns.”

The agency ordered the company to stop the promotion. In response, Pfizer told the FDA it would stop saying Zyvox was more effective against MRSA pneumonia than vancomycin.

Despite its 2005 pledge to the FDA, Pfizer continued to tell hospitals and doctors that Zyvox would save more lives than vancomycin, the company admitted in the September settlement.

By 2007, the criminal and civil cases against Pfizer, its employees and its subsidiaries had started to mount. The tally of drugs cited by federal prosecutors for off-label promotion reached six by 2009. In April 2007, P&U pleaded guilty to a felony charge of offering a $12 million kickback to a pharmacy benefit manager.

$2.2 Billion in Penalties

Pfizer paid a criminal fine of $19.7 million. Thomas Farina, a Pfizer district sales manager, was convicted in federal court in March 2009 for destroying records during the Bextra investigation. Farina, 42, was sentenced to three years on probation, including six months of home confinement. He didn’t return calls seeking comment.

Pfizer itself was called to account on Sept. 2, when it agreed to pay the $2.2 billion in fines and penalties. P&U pleaded guilty to a felony charge of misbranding Bextra with the intent to defraud. After the settlement, Pfizer general counsel Amy Schulman said the company had learned its lesson.

“We regret certain actions we’ve taken in the past,” she said. “Corporate integrity is an absolute priority for Pfizer.”

One reason drug companies keep breaking the law may be because prosecutors and judges have been unwilling to use the ultimate sanction -- a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.

“It’s potentially a death sentence for a drug company,” prosecutor Sullivan says.

Fig Leaf

A legal fig leaf allows a parent company to continue to participate in government programs even after its subsidiary has pleaded guilty.

Pfizer maintains its good standing with such agencies because its subsidiaries, Warner-Lambert and P&U, and not the corporation itself, entered the guilty pleas to felony charges.

A felony conviction of a pharmaceutical giant could lead to disaster for shareholders, Loucks says, adding that’s a step that may have to be taken for repeat offenders.

“I think it’s something the trigger will get pulled on,” he says from his ninth-floor office in the federal courthouse, with a sweeping view of Boston Harbor. “It’s just a question of when.”

At Pfizer’s Pharmacia sentencing on Oct. 16., U.S. District Court Judge Douglas Woodlock said companies don’t appear to take the law seriously.

“It has become something of a cost of doing business for some of these corporations, to shed their skin like certain animals and leave the skin and move on,” he said.

Eli Lilly

Lilly’s rap sheet goes back to 1985. That’s when the company pleaded guilty to 25 federal misdemeanor charges related to its misbranding of Oraflex, an arthritis drug.

Lilly stopped selling the drug four months after U.S. sales began in 1982, following the company’s failure to tell the FDA about illnesses and deaths tied to the medication. Lilly paid a $25,000 fine.

Twenty years later, in 2005, Lilly paid $36 million in a guilty plea to one federal misdemeanor for off-label marketing of Evista, a drug the FDA had approved for bone strengthening.

In 1997, the agency had rejected Lilly’s application to market the drug to reduce the risk of breast cancer. Yet beginning the next year, Lilly adopted an Evista marketing plan that included a seminar with doctors designed to appeal to women’s breast cancer concerns, Lilly admitted in its 2005 guilty plea.

In 2007, the FDA approved Evista for preventing breast cancer in two limited groups.

Back in Court

In January 2009, Lilly was back in federal court. Prosecutors in Philadelphia accused the company of earning hundreds of millions of dollars by illegally promoting its schizophrenia drug Zyprexa for the unapproved treatment of dementia from 1999 to at least 2003.

In 2001, Lilly’s senior management decided not to seek FDA approval for Zyprexa to treat dementia because of what they viewed as mixed results in clinical trials and safety risks, according to admissions by Lilly in its 2009 guilty plea. In its marketing, Lilly promoted the drug as effective.

Zyprexa has been Lilly’s best-selling drug for the past decade.

“Eli Lilly undertook this illegal off-label promotion for its own financial gain despite the potential risk to patients’ health and lives,” prosecutors wrote in their sentencing memo.

Lilly Chairman and CEO John Lechleiter said after the settlement that the company was devoted to acting responsibly.

‘Deeply Regret’

“We deeply regret the past actions covered by the misdemeanor plea,” he said. “Doing the right thing is nonnegotiable at Lilly.”

In a written response to questions from Bloomberg News, Lilly said, “Lilly entered into a very narrow guilty plea. Even though the company disagrees with and does not admit to the allegations, Lilly agreed to settle the dispute.”

Lilly paid $1.42 billion for a fine and penalties in the January settlement with federal and state governments. That included the largest criminal fine in U.S. history -- until Pfizer pleaded guilty in September.

The Justice Department could have charged Lilly with a felony. Prosecutors decided that it wouldn’t be fair to innocent Lilly employees, shareholders and pensioners to potentially shut down the company, according to the sentencing memo.

‘All the Factors’

“The government considered all the factors in its decision,” prosecutors wrote. “Those factors included other persons not proven personally culpable.”

Federal regulators have detected a similar pattern of dishonesty by other pharmaceutical firms. Schering-Plough Corp. drug salesmen pitched off-label uses of a cancer drug called Temodar at the American Society of Clinical Oncology’s annual conference in San Francisco in May 2001.

Schering-Plough representatives said Temodar compared favorably to a placebo in clinical trials for the off-label uses and was approved by the FDA for first-line use in treating brain tumors.

An FDA employee attending the conference took note. The next month, the FDA accused Schering of lying.

There had been no such clinical trials and the agency had not approved Temodar as the salespeople had claimed, the FDA said in a June 28, 2001, letter to Mary Jane Nehring, Schering’s senior director of marketed products. The agency ordered the company to immediately cease illegal promotion of Temodar.

Kenilworth, New Jersey-based Schering-Plough was quick to respond. On July 12, 2001, it wrote back to the FDA, assuring regulators that the San Francisco activity was an isolated incident.

‘Certainly Inconsistent’

“It was certainly inconsistent with the direction provided by the home office,” the drug company wrote, according to prosecutor’s records.

The FDA told Schering-Plough three weeks later that it had closed its investigation.

Schering-Plough didn’t stop pitching the drug for unapproved uses. At the direction of top management, Schering ordered widespread off-label marketing of Temodar and Intron A, another cancer drug, until December 2003, the company admitted in an August 2006 guilty plea.

Schering, which agreed in March to be acquired by Merck & Co., earned a pre-tax profit of $124.2 million from the illegal sales after promising the FDA in 2001 it would stop marketing for off-label uses, the company admitted.

Schering-Plough pleaded guilty in August 2006 to conspiring to make false statements to the FDA. The company agreed to pay $435 million to settle the case.

‘Upsetting to Me’

U.S. District Court Judge Patti Saris, who had presided over the Neurontin whistle-blower case before the Pfizer probe, accepted Schering’s plea in her Boston courtroom in January 2007. She expressed dismay with the drug industry.

“It’s been upsetting to me how many of the big pharmaceutical companies have engaged in what I view as clearly illegal behavior in terms of off-label marketing,” she said. “It almost seems as if the pharmaceutical companies said ‘Yeah, yeah, yeah’ to the FDA and then went and did it anyway.”

Brent Saunders, a Schering-Plough senior vice president, said after the settlement that his company had made great progress in putting integrity at the center of its work.

“With this agreement, we are putting issues from the past behind us,” he said. Schering declined to comment further.

As prosecutors continue to uncover patterns of deceit in off-label marketing by pharmaceutical companies, millions of patients across the nation remain in the dark. Doctors often choose the medications based on dishonest marketing by drug company salesmen.

‘A Morass’

“It’s a morass of undifferentiated information out there,” Public Citizen’s Lurie says. “And the doctors, let alone patients, aren’t able to distinguish the good from the bad.”

One thing all people should do, Lurie says, is ask whether their prescriptions are for FDA-approved uses, and if not, whether strong evidence supports using the drug, particularly if it can be dangerous.

Loucks says that putting an end to the criminal off-label schemes by the pharmaceutical industry is more difficult. As drugmakers repeatedly plead guilty, they’ve shown they’re willing to pay hundreds of millions of dollars in fines as a cost of generating billions in revenue.

The best hope, Loucks says, is that drug companies actually honor the promises they keep making -- and keep breaking -- to obey the law of the land.

Dad, where is Grandpa right now?

I tried not to tear up, but that didn't work . . .

Tricked On Halloween - Watch more Funny Videos

World's Scariest Stocks: Pfizer

Read the scary story in The Motley Fool.

The benefit of enemies, per John Cleese

As long as it feels good . . .

Eydie Gorme - Blame It On The Bossa Nova

Amy Winehouse - You´re Wondering Now

Vorm stadtpark die Laternen - Gitte Haenning & Rex Gildo

Auf Wiedersehen - Demis Roussos

I couldn't care less about Tom Cruise . . . but this spoof is funny!

Two-thirds of all the income gains from the years 2002 to 2007 — two-thirds! — went to the top 1 percent of Americans.

So, this is what's up.

Can't breath . . . get 'em off of me . . .heeeeelp!

Jogging across the street, oh noooooooooooooooooo!

I will not sign this letter

In 1961, New York Post columnist Leonard Lyons contacted John F. Kennedy after seeing Presidential autographs for sale in a store. At the time, George Washington’s was priced at $175, Ulysses S. Grant's at $55, Franklin D. Roosevelt's at $75, Teddy Roosevelt’s at $67.50, and JFK’s at $75. Below is the response mailed to Lyons.



For more amazing letters go to Letters of Note.

Letters of Note is an attempt to gather and sort fascinating letters, postcards, telegrams, faxes, and memos. Scans/photos where possible. Fakes will be sneered at. Updated 2-3 times every weekday.

75% of GOP Senators voted in favor of Halliburton's right to allow gang-rape of employees. No kidding.

Rape-Nuts

The Daily Show With Jon Stewart	Mon - Thurs 11p / 10c
www.thedailyshow.com
Daily Show Full Episodes Political Humor Ron Paul Interview

"Balloon Boy" Falcon Henne Says: "We Did This For The Show"

6-year-old Colorado boy floats away in balloon.

A 6-year-old boy in northern Colorado climbed into a hot-air balloon aircraft and floated away today, forcing officials to scramble to figure out how to rescue the boy. Balloon can fly as high as 10,0000 ft. I guess every American will watch television news tonight. No conclusion yet. Turn on CNN or FOX and watch live.

Genetics

A Canadian doctor diagnoses U.S. healthcare

The caricature of 'socialized medicine' is used by corporate interests to confuse Americans and maintain their bottom lines instead of patients' health.
By Michael M. Rachlis

Universal health insurance is on the American policy agenda for the fifth time since World War II. In the 1960s, the U.S. chose public coverage for only the elderly and the very poor, while Canada opted for a universal program for hospitals and physicians' services. As a policy analyst, I know there are lessons to be learned from studying the effect of different approaches in similar jurisdictions. But, as a Canadian with lots of American friends and relatives, I am saddened that Americans seem incapable of learning them.

Our countries are joined at the hip. We peacefully share a continent, a British heritage of representative government and now ownership of GM. And, until 50 years ago, we had similar health systems, healthcare costs and vital statistics.

The U.S.' and Canada's different health insurance decisions make up the world's largest health policy experiment. And the results?

On coverage, all Canadians have insurance for hospital and physician services. There are no deductibles or co-pays. Most provinces also provide coverage for programs for home care, long-term care, pharmaceuticals and durable medical equipment, although there are co-pays.

On the U.S. side, 46 million people have no insurance, millions are underinsured and healthcare bills bankrupt more than 1 million Americans every year.

Lesson No. 1: A single-payer system would eliminate most U.S. coverage problems.

On costs, Canada spends 10% of its economy on healthcare; the U.S. spends 16%. The extra 6% of GDP amounts to more than $800 billion per year. The spending gap between the two nations is almost entirely because of higher overhead. Canadians don't need thousands of actuaries to set premiums or thousands of lawyers to deny care. Even the U.S. Medicare program has 80% to 90% lower administrative costs than private Medicare Advantage policies. And providers and suppliers can't charge as much when they have to deal with a single payer.

Lessons No. 2 and 3: Single-payer systems reduce duplicative administrative costs and can negotiate lower prices.

Because most of the difference in spending is for non-patient care, Canadians actually get more of most services. We see the doctor more often and take more drugs. We even have more lung transplant surgery. We do get less heart surgery, but not so much less that we are any more likely to die of heart attacks. And we now live nearly three years longer, and our infant mortality is 20% lower.

Lesson No. 4: Single-payer plans can deliver the goods because their funding goes to services, not overhead.

The Canadian system does have its problems, and these also provide important lessons. Notwithstanding a few well-publicized and misleading cases, Canadians needing urgent care get immediate treatment. But we do wait too long for much elective care, including appointments with family doctors and specialists and selected surgical procedures. We also do a poor job managing chronic disease.

However, according to the New York-based Commonwealth Fund, both the American and the Canadian systems fare badly in these areas. In fact, an April U.S. Government Accountability Office report noted that U.S. emergency room wait times have increased, and patients who should be seen immediately are now waiting an average of 28 minutes. The GAO has also raised concerns about two- to four-month waiting times for mammograms.

On closer examination, most of these problems have little to do with public insurance or even overall resources. Despite the delays, the GAO said there is enough mammogram capacity.

These problems are largely caused by our shared politico-cultural barriers to quality of care. In 19th century North America, doctors waged a campaign against quacks and snake-oil salesmen and attained a legislative monopoly on medical practice. In return, they promised to set and enforce standards of practice. By and large, it didn't happen. And perverse incentives like fee-for-service make things even worse.

Using techniques like those championed by the Boston-based Institute for Healthcare Improvement, providers can eliminate most delays. In Hamilton, Ontario, 17 psychiatrists have linked up with 100 family doctors and 80 social workers to offer some of the world's best access to mental health services. And in Toronto, simple process improvements mean you can now get your hip assessed in one week and get a new one, if you need it, within a month.

Lesson No. 5: Canadian healthcare delivery problems have nothing to do with our single-payer system and can be fixed by re-engineering for quality.

U.S. health policy would be miles ahead if policymakers could learn these lessons. But they seem less interested in Canada's, or any other nation's, experience than ever. Why?

American democracy runs on money. Pharmaceutical and insurance companies have the fuel. Analysts see hundreds of billions of premiums wasted on overhead that could fund care for the uninsured. But industry executives and shareholders see bonuses and dividends.

Compounding the confusion is traditional American ignorance of what happens north of the border, which makes it easy to mislead people. Boilerplate anti-government rhetoric does the same. The U.S. media, legislators and even presidents have claimed that our "socialized" system doesn't let us choose our own doctors. In fact, Canadians have free choice of physicians. It's Americans these days who are restricted to "in-plan" doctors.

Unfortunately, many Americans won't get to hear the straight goods because vested interests are promoting a caricature of the Canadian experience.

Michael M. Rachlis is a physician, health policy analyst and author in Toronto.

Horror movie

The Fun Theory: How to get Swedish People to Choose the Stairs Instead of the Escalator

Obama won the Nobel Price for Peace?!

He hasn't been in office for more than six months . . . !

Two key White House aides were both convinced they were being punked when they heard the news, reported ABC News' George Stephanopoulos.

"It's not April 1, is it?" one said.

As for the impact on U.S. politics . . . it can only be for the better, so congratulations Mr. President!

Pharmalot back on Monday!

Ed Silverman is bringing back Pharmalot to life.

Story.

Daddy, don't go!

When Army Reservist Staff Sgt. Brett Bennethum lined up in formation at his deployment to Iraq this July, his daughter wouldn't let go.

Are you there? Wanna go somewhere? Okay!

Best new anti-smoking campaign ever launched by the government

New Anti-Smoking Ads Warn Teens 'It's Gay To Smoke'

Lars Bildman, former Astra CEO, known for his love of sexy sales reps, wild parties and crazy clothes, must return $7 million in pay.

Some people claim a book is being written about his story, and former reps and employees have been going on about him, telling memories right here for the last few years.

There is hate and love (a bit too much love according to some) and very little in between, just like any Shakespearean drama.

It all started with a story in BusinessWeek, later he was arrested by federal authorities and charged with 35 counts, including fraud and tax evasion. Astra sued him, claiming he sexually harassed and intimidated employees, destroyed documents and records, and concocted "tales of conspiracy involving ex-KGB agents and competitors...in a last-ditch effort to distract attention from the real wrongdoer; Bildman himself." The suit also said he used company funds to rent yachts and pay for prostitutes.

Bildman plead guilty to failing to report over $1 million in income and agreed to serve 21 months in a federal prison. He also had to pay the government more than $ 300,000 in back taxes and interest.

Massachusetts’ highest court yesterday ruled that the former chief executive of Westborough pharmaceutical company Astra USA Inc. must forfeit nearly $7 million in salary and bonuses he collected from 1991 through 1996, when he was fired for harassing female employees and misappropriating company funds.

Reversing the decision of a lower court judge, who ruled Astra could not recover compensation paid to Lars Bildman, the Supreme Judicial Court opinion cited the law of New York state, where Astra was incorporated, pertaining to corporate officers who breach their fiduciary duty.

In a 21-page decision, the state’s high court justices said New York’s “faithless servant’’ doctrine allows the company to go after $5.6 million in salary and $1.2 million in bonuses paid to Bildman.

The decision upheld Suffolk Superior Court Judge Margaret Hinkle on several other issues in the long-running litigation, but its reversal on the forfeiture question appeared to close the curtain on the high-profile sexual harassment and embezzlement case.

Company attorney Jeff Robbins, a partner at Boston law firm Mintz Levin, hailed the high court’s decision to force Bildman to forfeit his compensation. Robbins said the ruling was not only important in Massachusetts and New York, but could set a national precedent if other states embrace New York’s forfeiture standard.

“Given the prominence of this case and given the forcefulness of the court’s ruling, this is a holding that could have national significance in the area of forfeiture law,’’ he said.

Robbins represented Astra’s successor company - drug maker AstraZeneca, based in England - before the Supreme Judicial Court. AstraZeneca was formed through a 1999 merger between Britain’s Zeneca Group PLC and Sweden’s Astra AB, the parent of Astra USA.

Corporate boards face mounting pressure to crack down on executives who breach their fiduciary duty, said Thomas C. Kohler, a Boston College law professor. He said courts are likely to see more cases of companies trying to recoup compensation from wrongdoers.

“This is going to become an issue of greater and greater import,’’ Kohler said. “This decision in Massachusetts may give other courts a framework for ruling on similar kinds of cases. But what one state does is not necessarily of pressing interest to other states.’’

At the US office of AstraZeneca in Wilmington, Del., spokeswoman Laura Woodin said the court ruling “validates the actions of Astra USA to hold its former executive accountable for his conduct and allows our company to move forward.’’

Bildman, the Swedish-born executive at the center of the case, yesterday said he is retired and living in Vermont on Social Security. He said his wife divorced him as a result of the case and that he has spent nearly all the money he earned defending himself in court.

“Of course I am disappointed,’’ Bildman said. “It would be impossible not to be disappointed. The money doesn’t concern me at all. I have no money, so it will be uncollectable.’’

Michael D. Weisman, attorney for Bildman, said he could not discuss the ruling in detail until he had conferred with his client. But he noted that the court upheld lower court rulings that awarded Bildman about $200,000 in damages in connection with a stock grant, prevented Astra from rescinding an employment agreement with him, and held that his client did not have to pay the costs of Astra’s investigation.

“I’m grateful that the court reaffirmed many of the important issues in which Bildman prevailed in the court below,’’ said Weisman, a partner at the Boston law firm of Weisman & McIntyre.

Bildman was fired in 1996 after an internal investigation found he and other managers harassed female employees at Astra in Westborough and that he spent company money on home repairs, vacations, and high-priced prostitutes. Women at the company said Bildman engaged in “up-close and personal conduct’’ and they were under relentless pressure to dress provocatively and to socialize with Bildman and other executives to ensure their employment. The allegations were first reported in BusinessWeek magazine.

In 1997, a federal grant jury sitting in Massachusetts indicted Bildman on multiple counts. He ultimately pleaded guilty to falsifying tax returns and served an 18-month prison sentence.

Astra, meanwhile, agreed in 1998 to pay $9.8 million to settle charges brought by the US government, in what then was the largest sexual harassment case in the history of the Equal Employment Opportunity Commission. Separately in 1998, the company sued Bildman in superior court for misuse of funds, fraud, and breach of fiduciary duty, while he countersued Astra for wrongful termination.

A jury ruled against Bildman on 24 of 25 counts in 2002. He appealed, setting up yesterday’s decision.

Seven rules for successful negotiations

1. Understand who you negotiate with. Call it empathy. There’s no substitute for understanding the other side of the negotiation. What do they really want?

2. Find the win-win. Either both parties lose or both parties win. Find out what they need to win and you may win as well. So look for that in every negotiation.

3. Everything is negotiable. Don’t narrow a negotiation down to just one issue. Develop as many negotiable deal points as may apply and give the other party options.

4. Be honest and fair. One uncovered lie will destroy the negotiation. You may not like the other party, but there must be trust to complete a negotiation.

5. Use the power of competition. What are your alternative options if you don’t reach a deal and how will that affect you and the other party?

6. Humans don’t appreciate what they don’t have to fight for. The longer the negotiation, the more each party have invested in finding a solution.

7. Be prepared to walk away. If you are wedded to the thought of reaching a deal you will lose. Prepare an exit strategy.

Notice anything in this wedding picture that didn't exist ten years ago?

Hint: Check out the priest.

Would you send your children to school if "only 5%" of teachers were involved in child sex abuse?

Quote of the day from the Catholic Church:

The statement, read out by Archbishop Silvano Tomasi, the Vatican's permanent observer to the UN, defended its record by claiming that "available research" showed that only 1.5%-5% of Catholic clergy were involved in child sex abuse.

Health Care in London

9/9/2009 By Thomas P. Beresford, MD
I was in London four weeks ago when around 11 p.m., I felt a sharp pain. I feel for a point on my body - a third of the distance from the right hip bone to the belly button. Pressing ever so lightly, the right side of my belly lights up with pain as though on fire. I can not stand.

Using what I call a cell and the British call a mobile, I phone the night manager, who then calls the paramedics. With an IV line and morphine in the ambulance, they take me to St. Mary's Hospital Paddington. "Is that hospital any good," I ask. "Oh yes," he says. "And don't worry, the Accident and Emergency visit is free."

An Irish nurse tends to me, watching my vital signs and the pain. Then comes an emergency service doctor and then a junior followed by a mid-level surgeon - what we call residents. I received chest and abdomen X-rays and then a CT scan of the belly.

I was admitted to a surgical ward in the early hours. "We don't want to operate on your appendix in the middle of the night," my doctors told me. "We want you to see the Specialist Registrar who is the most practiced at laparoscopic (surgery through a tube) work through the belly button."

I meet him the next afternoon. He has the self confidence of his profession. "I am what you might call the 'Chief Resident' in your system." I grin.

"I was one of those myself but in psychiatry," I tell him. Eye to eye, we exchange knowing and assertive glances, one Chief to another.

I go under and wake six hours later on the ward wearing an oxygen mask, a dressing over my belly button and a drain stitched in lower down. As I clear, I begin to try deep breathing to keep my lungs clean. The fire is gone. There is soreness, but I can cough.

The nurse tells me it's too early to walk. I'm on IV fluids and antibiotics with less pain killer but enough to cover. The next day I don't need any. The first night I drift in and out of sleep as my water output returns.

At 3 a.m. another junior surgeon and a student wake me to be sure the repair does not leak. I have no pain, and none when she gently tests the right side of my belly.

The team and the mid-level resident see me the next morning. "You had a nasty appendix," the team tells me. "The tissue was dead and leaking into the abdomen. The surgery usually takes twenty minutes. Yours took ninety. They were surprised you could walk to the anesthesia suite."

The Specialist Registrar stops by in mid-afternoon and says, "I was worried. We've watched you closely and will for a few more days. But the worst is over." Then he grins and says eye-to-eye "You're a tough man." I said, "Thanks."

I went back to the hotel two days later, pain free, walking, able to shower, then to sleep, and easing back into an appetite.

I've been a physician and a professor in American medical schools for nearly 40 years. I've heard all the arguments against universal coverage and all the stale criticisms of the National Health Service. When I tell a friend about the NHS, fresh off my surgery in Britain, she says "I've been paying lots of good money for health insurance for years."

"And what have you got to show for it besides the receipts?" I ask her.

Look what we all could have for far less than it costs to fund insurance companies and malpractice lawyers. Health care for everyone. If Britain can do it, the U.S. certainly can.

Thomas P. Beresford, MD, is a professor of Psychiatry at the Department of Veterans Affairs Medical Center and School of Medicine at the University of Colorado Denver.

Conception

Mahmoud Ahmadinejad's Gmail Inbox Hacked!!

Beauty

Baby did a bad bad thing . . .