Lilly Paid Doctors to Prescribe Zyprexa, Notes Show

Bloomberg News
By Margaret Cronin Fisk and Jef Feeley

Sept. 8 (Bloomberg) -- Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.”

The notes were made public for the first time in a court hearing today in South Carolina in the state’s lawsuit against Lilly over Zyprexa marketing practices. State officials contend Indianapolis-based Lilly marketed the drug for unapproved uses. A trial is set to begin Sept. 14.

South Carolina wants to recoup $200 million it contends it wrongfully spent on Zyprexa prescriptions as a result of Lilly’s push to get doctors to use the medicine, approved only for schizophrenia and bipolar disorder, for other ailments. The state also contends the drugmaker withheld information about Zyprexa’s side effects, such as weight gain.

“Call notes are jottings written by sales reps and most reps make hundreds of notes monthly. They are not literal recitations of interactions with physicians,” Marni Lemons, a Lilly spokeswoman, said in telephone interview.

‘Out Of Context’

Lemons said the state’s lawyers took the notes “out of context” and “not one physician employed by the state of South Carolina has testified Lilly promoted off-label to them.”

The notes became public at a hearing in Spartanburg, South Carolina, on Lilly’s motion to have the state’s case thrown out prior to trial.

The state also is seeking a $5,000 fine for each Zyprexa prescription dating back to 1997, according to court filings. That could result in billions of dollars in fines, South Carolina’s lawyers say.

Lilly resolved a marketing investigation over Zyprexa in January with the U.S. Justice Department, promising to pay $1.42 billion, including about $362 million to more than 30 states. South Carolina opted not to join that settlement.

Alaska Settlement

The only trial of a state’s lawsuit ended in March 2008 with an out-of-court settlement in which Lilly agreed to pay Alaska $15 million.

Zyprexa, part of a class of medications called atypical antipsychotics, has been linked to excessive weight gain and diabetes. The lawsuits also claim Lilly failed to properly warn of Zyprexa’s side effects.

Lilly officials have denied the drugmaker withheld information about Zyprexa’s side effects or improperly marketed the drug in South Carolina.

Lawyers for the state pointed to a sales note from Sullivan in which he tells another salesman to tie a doctor’s Zyprexa prescriptions to participation in a speakers’ program.

The company paid doctors and psychiatrists to address physician gatherings about the benefits of the antipsychotic. “If his numbers go up, maybe he can talk,” Sullivan said in the August 2001 note.

‘So Much Money’

A year later, Sullivan noted in sales records that he was pressing a doctor to write more Zyprexa prescriptions “because we’re paying him so much money” to participate in the speakers’ program, according to a call note made public today.

Lilly also offered other inducements to doctors who prescribed Zyprexa, such as deep-sea fishing trips and Palm- Pilot devices, said John Simmons, a Columbia, South Carolina- based lawyer representing the state.

The sales notes show that many of those prescriptions were for unapproved, or so-called off-label, uses, Simmons told Judge Roger Couch.

The U.S. Food and Drug Administration regulates what drugs can be used to treat specific ailments. Drugmakers can only promote their medicines for FDA-specified illnesses.

Faced with the loss of patent protection for its Prozac antidepressant, Lilly officials pushed salespeople to market Zyprexa for a host of ailments, including depression, agitation and anger, Simmons said. The FDA hadn’t approved the drug for any of those uses, he added.

‘Diamond’

Company officials said in a memo that they were “betting the farm on Zyprexa” to replace Prozac, Simmons said.

In internal memos, Lilly officials used the word “diamond” as a code for talking about their Zyprexa off-label marketing campaign, he said.

He cited notes from visits with doctors in 2000 and 2001 where sales reps reported talking about older patients being treated with Zyprexa for agitation and declining mental acuity.

Simmons noted the drugmaker already pleaded guilty to a criminal charge over its off-label promotion of Zyprexa for use with elderly patients.

In that plea, Lilly officials acknowledge that the company illegally pushed the drug’s off-label use by older patients from Sept. 1, 1999, to March 31, 2001.

The company also pushed primary-care physicians to use the antipsychotic medication on children, Simmons said. One of the notes indicated salespeople said the drug is ‘for kids whose parents have to shove the pills down their throat every day.”

‘In His Tea’

Another note shows that one doctor told Lilly he was prescribing Zyprexa for a 13-year-old, whose mother “puts it in his tea.”

Besides illegally marketing its drug, South Carolina officials contend Lilly violated the state’s unfair trade practices law by mishandling Zyprexa and unjustly enriched itself at the state’s expense.

Lilly’s lawyers have countered in court filings that the company didn’t engage in fraud in its handling of Zyprexa or misrepresent the drug’s strengths and weaknesses.

They contend South Carolina officials have no evidence of illegal marketing within the state, either from private doctors or those working with state agencies.

“At least 12 state officials, including state physicians who prescribe Zyprexa, testified that they were not misled by Lilly,” the lawyers said in the filings.

The state can’t produce a single South Carolina doctor who’ll testify they’ve received “communications from Lilly regarding off-label promotion of Zyprexa,” according to the filings.

The South Carolina case is State of South Carolina v. Eli Lilly & Co., 2007-CP-42-1855, Common Pleas Court for South Carolina’s Seventh Judicial Circuit (Spartanburg).

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net; Jef Feeley Spartanburg, South Carolina, at jfeeley@bloomberg.net.

The CIA Mind Control Doctors: From Harvard to Guantanamo

The CIA Mind Control Doctors: From Harvard to Guantanamo
by Colin A. Ross
Psychiatrist, Author,
The CIA Doctors, Military Mind Control
and Project Bluebird

(click above for a 3-minute video by Dr. Colin Ross regarding psychiatry/CIA mind control)

My book, The CIA Doctors,[i] is based on 15,000 pages of documents I received from the CIA through the Freedom of Information Act and dozens of papers published in medical journals. These papers report the results of research funded by the Air Force Office of Scientific Research, the Department of the Army, the Office of Naval Research and the CIA. From 1950 to 1972, the CIA funded TOP SECRET research at many leading universities including Harvard, Yale, Cornell, Johns Hopkins and Stanford. There was a series of CIA mind control programs including BLUEBIRD, ARTICHOKE, MKULTRA, MKSEARCH and MKNAOMI.

MKULTRA and related programs had several over-lapping purposes. One was to purchase mind control drugs from suppliers. Another was to form relationships with researchers who might later be used as consultants at the TOP SECRET level. The core purpose of these programs was to learn how to enhance interrogations, erase and insert memories, and create and run Manchurian Candidates. All of this is described clearly and explicitly in the declassified CIA documents, which provide a glimpse into the tip of the iceberg of CIA and military mind control.

The CIA mind control experiments were interwoven with radiation, chemical and biological weapons experiments conducted on children, comatose patients, pregnant women, the general population and other unwitting groups who had no idea they were subjects in secret experiments. Radiation, bacteria and funguses were released over urban areas. A large cloud of radiation was released over Spokane during OPERATION GREEN RUN; plutonium was injected into a comatose patient in Boston by Dr. William Sweet, a member of the Harvard brain electrode team; plutonium was placed in the cereal of mentally handicapped children at the Fernald School in New England; 751 pregnant women were injected with plutonium at Vanderbilt University; the bacteria serratia maracens was released into the air in San Francisco, resulting in a series of infections and plutonium was injected into an amputee at the University of Rochester. All these experiments were conducted without any informed consent or meaningful follow-up. Hallucinogens, marijuana, amphetamines and other drugs were administered to imprisoned narcotic addicts in Lexington, Kentucky, terminal cancer patients at Georgetown University Hospital, hospitalized sex offenders at Ionia State Hospital in Michigan and johns picked by prostitutes hired by the CIA in San Francisco and New York.

Most of these experiments were conducted by psychiatrists with TOP SECRET clearance. These included Louis Jolyon West, Chairman of the Department of Psychiatry at the University of Oklahoma and later at UCLA; Dr. Robert Hyde in Boston; Dr. Carl Rogers at the University of Wisconsin; Dr. Martin Orne at Harvard; Dr. Charles Osgood at the University of Illinois; Dr. James Hamilton at Stanford; Dr. Charles Geschichter at the University of Richmond and Dr. Harold Abramson and Dr. Harold Wolff at Cornell. Other TOP SECRET-cleared MKULTRA contractors included Dr. Maitland Baldwin, a neurosurgeon at the National Institutes of Health and Dr. Carl Pfeiffer, a pharmacologist at Emory.

The CIA doctors violated all medical codes of ethics dating back to Hippocrates, including the Nuremberg Code. The experimental subjects were not told the real purpose of the experiments, did not give informed consent, were not afforded outside counsel and received no meaningful follow-up. As described by the psychiatrists in published papers, experiments with LSD and other hallucinogens, combined with sensory deprivation, electroshock and other interrogation techniques, resulted in psychosis and death among other “side effects.” The purpose of these experiments was to see how easily a person could be put into a psychotic state or controlled.

In a series of MKULTRA projects, the CIA paid a former Bureau of Narcotics officer, George White, to set up safe houses in San Francisco and New York that were decorated like brothels. George White then hired prostitutes to pick up johns at bars, bring them back to the safe house, give them LSD without their knowledge, and then have sex with them. The CIA officers watched the sex through one-way mirrors. The project documents state that the purpose of the experiments was to test the effects of LSD on unwitting subjects under field conditions that mimicked an interrogation of a foreign operative.

In one of the memos contained in the MKULTRA files for these projects, however, another purpose of the safe house operation is revealed. The CIA was actually testing the performance of “Jekyll-Hyde” identities they had created in the prostitutes. They wanted to see if they could make female spies or female agents with alternate controllable personalities. Another purpose of these experiments was to test the CIA’s Manchurian Candidate prostitutes under conditions that mimicked a field operation. The johns were given LSD as part of the cover for testing the CIA’s female Manchurian Candidates prior to their use in actual operations (the mission being to have sex with and extract information from targets). The recruitment of street prostitutes provided an additional layer of cover for the testing of the Manchurian Candidates, plus it provided free live pornography for the CIA officers.

In other experiments, conducted by Dr. Jose Delgado at Yale and Drs. Vernon Mark, Frank Ervin and William Sweet at Harvard, brain electrodes were implanted in people and their mental state and behavior was controlled from a remote radio transmitter box. These experiments were conducted with funding from the Office of Naval Research. In experiments at Tulane funded by the CIA and the Army, implantation of brain electrodes was combined with injecting mescaline and other substances directly into the experimental subjects’ brains.

BLUEBIRD, ARTICHOKE and MKULTRA were the precursors of present-day enhanced interrogation programs used by the CIA at secret prisons outside the United States. Water-boarding, electric shock, hooding, prolonged sleep deprivation, death threats and other techniques discussed in the Senate and Congress and in the media, are, in my opinion, elements of a limited hangout, a CIA strategy in which a little bit of the truth is revealed in order to cover up the greater part of the truth. None of these experiments or operational programs would be possible without the participation of doctors, psychiatrists and psychologists. The doctors are directly involved in testing the interrogation techniques and monitoring their effects.

The purpose of mind control experiments is controlling human behavior: making enemy combatants open up during interrogation; protecting secret information by erasing memories; making spies more resistant to interrogation because secret information is held by hidden identities and making people more prone to influence, social control and suggestion. It has nothing to do with medical treatment, easing suffering or curing disease. The mind control experiments and operational programs violate basic human rights and all codes of medical ethics.

Dr. Colin Ross is a psychiatrist, internationally renowned researcher, author and lecturer. In addition to The CIA Doctors and Military Mind Control, he is also author of Project Bluebird, in which he exposes unethical experiments conducted by psychiatrists to create amnesia, new identities, hypnotic access codes, and new memories in the minds of experimental subjects. His research is based on 15,000 pages of documents obtained under the Freedom of Information Act. Dr. Ross is a past president of the International Society for the Study of Dissociation. He is the founder and President of the Colin A. Ross Institute for Psychological Trauma.

Pfizer's huge fine: A disturbing trend Do the increasing penalties against drug companies really cure the problem?

Salon.com
By Vincent Rossmeier
Sep. 03, 2009 |

$2.3 billion: That's the price pharmaceutical giant Pfizer agreed to pay in a settlement Wednesday over its misleading marketing for the painkiller Bextra, the antipsychotic Geodon, the antibiotic Zyvox, and another painkiller, Lyrica. It's a record settlement that included the highest fine charged in U.S. history and came as the result of a lengthy Department of Justice investigation into healthcare fraud.

Though Pfizer voluntarily withdrew Bextra from the market in 2005, in the settlement, the company concedes that they had pushed doctors to prescribe unsafe doses of the drug prior to that point. The drug was approved by the FDA in 2001 for the treatment of pain associated with menstrual cramps and arthritis, but Pfizer encouraged its sales representatives to entice doctors to prescribe the drug in doses higher than those approved by the FDA. The escalated doses increased the chances that users of the drug would suffer a heart attack or a stroke. Pfizer also marketed Zyvox as a treatment for specific kinds of bacteria on which the drug had no effect.

A former Pfizer sales representative, John Kopchinski, whose questioning of the company's marketing tactics helped lead to the investigation, will receive over $51 million from the settlement. Kopchinski lost his job as a result of blowing the whistle on Pfizer's illegal schemes. Pfizer will have to pay settlements in 42 states and the District of Columbia.

However, the hefty cost will probably barely affect Pfizer's overall profit margins: The company purchased rival Wyeth in January for $68 billion and had revenues of over $48 billion last year. As the New York Times pointed out, "While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales." This is the fourth time Pfizer has reached a settlement over fraudulent marketing since 2002.

In the wake of Pfizer's settlement, here's a look at some of the larger Big Pharma settlements in recent history:

* Zyprexa, 2009 -- Eli Lilly was accused of selling its top-selling drug Zyprexa widely -- even to those people without bipolar disorder or schizophrenia for which the drug was supposed to be used. The drug can cause severe weight gain, as well as increasing the risk of a patient developing diabetes. In January, Eli Lilly reached a settlement with the government for $1.4 billion.
* OxyContin, 2007 -- Introduced in 1996 by Purdue Pharma, OxyContin was advertised as a softer, gentler painkiller. However, the drug is actually highly addictive, acting like heroin if taken incorrectly. OxyContin has become a scourge to communities across the U.S. and has also led to numerous overdose deaths. Perhaps the most notorious abuser of OxyContin was conservative radio talk show host Rush Limbaugh. In 2007, Purdue Pharma agreed to cough up $634.5 million in fines for its false claims about the drug.
* Vioxx, 2007 -- When 47,000 people are involved in a lawsuit against you, you know you have a problem. Thus, Merck, the maker of the painkiller Vioxx, reached a $4.85 billion settlement in 2007 to get rid of all the pending cases brought against it due to Vioxx's negative side effects. Vioxx was found to double the risk of heart attacks and strokes and thus Merck pulled the pill from pharmacies in 2004.
* Serostim, 2005 -- Serono, a Swiss technology company, had to pay $700 million in 2005 as a result of its fraudulent marketing for the AIDS drug Serostim. Serono developed a test that inflated the seriousness of the symptoms of a patient afflicted with AIDS and also sponsored junkets for doctors in order to get them to prescribe the drug.
* Neurontin, 2004 -- Pfizer reached a settlement of $430 million to end criminal and civil charges about its practice of paying doctors to prescribe Neurontin, a drug for epilepsy, to patients with bipolar disorder, for which it was not approved.
* Cipro, 2003 -- Bayer reached a $257 million settlement in 2003, the largest Medicaid fraud settlement at that time, after being charged by federal investigators with overcharging for the antibiotic Cipro. Bayer, however, didn't act alone: It received advice on how to go about the scheme from healthcare giant Kaiser Permanente.
* Paxil and Flonase, 2003 -- GlaxoSmithKline allegedly didn't want to miss out on all the fun and profits Bayer was having in overcharging for Cipro. It was accused of running a scheme with Kaiser Permanente to bilk Medicaid for the antidepressant Paxil and the allergy spray medication Flonase. GlaxoSmithKline paid $87.6 million in 2003 to settle the case.
* Lupron, 2001 -- TAP Pharmaceuticals Inc. came up with a clever way to get doctors to use its prostate cancer drug, Lupron, instead of those of rival drug companies: namely, pay them. TAP offered one doctor $25,000 to go back to prescribing Lupron after he'd switched to a competitor's drug. But the doctor alerted authorities, who conducted a massive sting resulting in TAP dishing out a $875 million settlement in 2001.
* Fen-Phen, 1999 -- Billed as a miracle diet drug by the drug company American Home Products Corp. (AHP), Fen-Phen was just as good at promoting heart valve disease as it was at helping people shed excess pounds. AHP removed Fen-Phen in 1997 after a damaging report showed that those who took the drug for more than two years increased their risk of developing heart valve disease by 17 percent. Though AHP agreed to pay $3.75 billion to the users of the drug, it did not have to admit to any wrongful actions in its marketing of Fen-Phen.

Doc Who Urged Antipsychotics for 3-Year-Olds Funded by J&J, AZ and Shire

BNET
By Jim Edwards | Aug 28, 2009

A doctor who wrote in an academic journal that preschoolers may suffer from depression and could be good candidates for atypical antipsychotics received funding from three drug companies that make mental health medicines.

Dr. Joan Luby, a professor of child psychiatry at the Washington University School of Medicine in St. Louis, wrote that children as young as three years old may suffer from bipolar disorder, and that there are “promising findings for the use of atypical antipsychotic agents and mood stabilizers, both singly and in combination” in the very young. Atypical antipsychotics are not FDA-approved for such use.

Her article, in a 2009 journal titled Child and Adolescent Psychiatric Clinics of North America, does not disclose that in the past Luby’s work has been funded by Janssen (the unit of Johnson & Johnson that markets Risperdal), or that she has given talks sponsored by AstraZeneca (maker of Seroquel), and has been a consultant for Shire (maker of Adderall XR and Vyvanse).

Luby (pictured) disclosed her relationships with drug companies in a 2006 article in the Journal of the American Academy of Child & Adolescent Psychiatry, which was also about depression in preschoolers. Her disclosure said:

Disclosure: Dr. Luby has received grant/research support from Janssen, has given occasional talks sponsored by AstraZeneca, and has served as a consultant for Shire Pharmaceuticals.

Luby did not return an email or two phone calls requesting comment. It is not clear whether academic journal rules at the time required her disclosures. AZ said:

AstraZeneca records show that Dr. Luby participated in our speakers program from 2003-2004. It is AstraZeneca policy to compensate speakers according to the fair market value of their services.

After checking its records, Shire said it paid $2,000 to Luby in 2004, plus a $19 in travel expenses.* J&J did not respond to a message requesting comment.

Luby is not the only academic researcher whose disclosure of Big Pharma funding has been spotty. Sen. Chuck Grassley, R-Iowa, is pushing for transparency legislation that would force all university researchers to disclose their ties to drug companies.

A selection of Luby’s published papers on childhood depression shows that while in 2006 she did disclose her payments from drug companies, in 2007 she did not. In an article titled “Psychotropic Prescriptions in a Sample Including Both Healthy and Mood and Disruptive Disordered Preschoolers,” in the Journal of Child and Adolesent Psychopharmacology, Luby’s disclosure statement said:

The authors do not have any corporate, commercial, or financial relationships that pose conflicts of interest.

Also in 2007, Luby signed as an author to a “Special Communication” in the same journal written by a group of child psychiatrists called The Preschool Psychopharmacology Working Group. The purpose of their group, Luby and her colleagues wrote, was:

… to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications.

The other authors of that paper disclosed a wealth of company ties, including Eli Lilly, Organon, Forest Labs, GlaxoSmithKline, Wyeth-Ayerst, McNeil, Novartis, Pfizer, Bristol-Myers Squibb, Abbott, AstraZeneca, Sepracor, Cephalon, Sanofi-Aventis, Boehringer-Ingelheim, and Janssen. Regarding Luby, the paper said:

The other authors have no financial relationships to disclose.

In Luby’s 2009 editorial, she wrote:

The need for large-scale and focused studies of this issue is underscored by the high and increasing rates of prescriptions of atypical antipsychotics and other mood stabilizing agents for preschool children with presumptive clinical diagnosis of bipolar disorder.

She cited a paper by Harvard’s Dr. Joseph Biederman, who was subpoenaed by federal prosecutors investigating J&J’s promotion of Risperdal, much of which was allegedly off-label to children. Separately, hundreds of lawsuits have been filed alleging that Seroquel has dangerous side effects such as weight gain and diabetes.

*Correction: Shire originally said it had no contact with Luby in the prior two years.

* Related:
* Biederman’s Finances: He Names His Own Price, and It’s $550 an Hour
* AstraZeneca Q2: $593M Seroquel Legal Bill Taps Out Insurance; Income Charges Expected

Pfizer Pays $2.3 Billion to Settle Marketing Case

New York Times
September 3, 2009

By GARDINER HARRIS
,
WASHINGTON — The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

It was the largest health care fraud settlement and the largest criminal fine of any kind ever.

Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.

“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.

Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.

“Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,” said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again.

“The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,” she said.

The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.

Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave.

John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra.

“The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” said Mr. Kopchinski, whose personal share of the Pfizer settlement is expected to exceed $50 million. Mr. Kopchinski left Pfizer in 2003.

Altogether, six whistle-blowers will collect $102 million from the federal share of the settlement and more from states’ shares. Forty-nine states and the District of Columbia will collect $331 million, with New York State alone getting $66 million. Only South Carolina chose not to participate in the settlement.

As news of the riches earned by whistle-blowers spread through the industry in recent years, scores of fraud cases have been filed by former drug sales representatives using a Civil War-era law that pays a bounty for fraud alerts. The cases charge that illegal drug marketing cost the federal Medicare and Medicaid program millions.

Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors.

Consumer advocates heaped scorn on Pfizer and said that illegal marketing was still common in the drug industry.

“Consumers should ask their doctor whether the medication being prescribed is F.D.A.-approved for their condition,” advised Lisa Gill, editor of Consumer Reports Best Buy Drugs. If a drug is not approved for their condition, patients should press their doctors to explain their reasoning for the drug’s use.

Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well.

Dr. Scott Gottlieb, a top F.D.A. official in the Bush administration who now consults for drug makers, said that government prosecutors were increasingly criminalizing “what reasonable people might argue is a reasonable exchange of important clinical information between drug companies and doctors.”

Bextra was approved in 2001 by the Food and Drug Administration to treat arthritis and menstrual cramps. The drug was not approved for the treatment of acute pain, nor was it shown to be any more powerful than ibuprofen. But Pfizer instructed its sales representatives to tell doctors that the drug could be used to treat acute and surgical pain and at doses well above those approved, even though the drug’s dangers — which included kidney, skin and heart risks — increased with the dose, the government charged. The drug was withdrawn in 2005 because of its risks to the heart and skin.

Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics.

“Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there,” he said. Such weekend getaways for doctors are still common throughout the drug and medical device industries.

Top Republican officials rarely publicized drug marketing cases or appeared during news conferences about them. Eli Lilly agreed to pay $1.4 billion over its marketing of Zyprexa, an antipsychotic, in January, before President Obama took office. The announcement was made by prosecutors in Philadelphia.

Ms. Sebelius’s decision to make the Pfizer announcement in Washington suggests that the political environment for the pharmaceutical industry has become more treacherous despite the industry’s commitment to save the government $80 billion as part of efforts to change the health care system.

Copyright 2009 The New York Times Company