Psych Diagnoses Fraud Leads to Pharmaceutical Prosecutions

NowPublic.com
Kevin Hall
October 8, 2012

Nearly all major psychiatric drug manufacturers have been convicted of illegal marketing and/or fraudulent claims. Several of these cases are linked below. Any that haven't been prosecuted, probably should be.

The reason behind this is simple. There are no medical tests to confirm or deny any mental disorder or diagnoses. A few decades back, psychiatrists "voted" that mental "illness" was caused by a "chemical imbalance of the brain." This is drug marketing, not science. Nobody votes in diabetes or cancer as medical disease and there are sound medical and lab tests for these and other medical diseases.

Psychiatric diagnoses is merely opinion of behavior. Psychiatrists simply vote on what is or is not a mental disorder and place these diagnoses into the American Psychiatric Association's "Diagnostic and Statistical Manual." Their controversial DSM5 is set to be released in 2013 and will likely lead to more pharmaceutical fraudulent marketing prosecutions and settlements.

The reason is simple. If there is no identifiable disease, there can never be a drug that will cure. In fact, there are no cures for any mental disorders. The drugs are generally uppers (ADHD drugs) or downers (anti-anxiety drugs and antipsychotics) that merely mask symptoms in some cases while having extremely dangerous side effects. The upper-type antidepressants have been proven to be very little, if any, more effective than a placebo (sugar pill) yet greatly increase sexual dysfunction while also increasing the likelihood of violence and suicide. Honest marketing would refer to them as anti-sex drugs.

The flow (explained and graphed here) is that psychiatrists create a disease by voting, then pharmaceuticals make the drug. Psychiatrists, usually at major universities, create fraudulent studies that the FDA approves on the word of the drug companies that funded the studies. Once they get approval for a certain condition (such as depression) and population (such as men over age 18, etc.), they get some paid-off psychiatrist to create and get published a study saying that the drug is helpful for other populations and diagnoses. This allows for what is termed off-label prescribing.

It's all fraud and all prosecutable.

The story printed below on Abbott Labs (Depakote) came out last week. It's the Virginia Attorney General's press release www.oag.state.va.us/Media%20and%20News%20Releases/News_Releases/Cuccinelli/100212_Abbott_Labs.html .
Here are some other links to recent settlements with:

GlaxoSmithKline (Paxil) http://www.justice.gov/opa/pr/2012/July/12-civ-842.html ;

Johnson & Johnson, (Risperdal, Invega) www.nytimes.com/2012/04/12/business/drug-giant-is-fined-1-2-billion-in-arkansas.html?_r=0, www.bloomberg.com/news/2012-08-30/j-j-will-pay-181-million-to-settle-risperdal-ad-claims.html, http://www.bloomberg.com/news/2012-08-31/j-j-loses-appeal-of-257-7-million-risperdal-verdict.html  ;

Pfizer, (Zoloft,Geodon, etc.) www.msnbc.msn.com/id/32657347/ns/business-us_business/t/pfizer-pay-record-billion-penalty/#.UHLjXVF_P1U ;

Astrazeneca, (Seroquel) www.azcentral.com/business/articles/2010/04/27/20100427astra-zeneca-settlement.html ;

Bristol-Myers Squibb (Abilify) www.justice.gov/opa/pr/2007/September/07_civ_782.html ;

Eli Lilly (Zyprexa) www.justice.gov/opa/pr/2009/January/09-civ-038.html .

Maybe it is time that some of the psychiatrists creating the fraudulent diagnoses and studies start getting criminally prosecuted for fraud?


Commonwealth of Virginia
Office of the Attorney General


For media inquiries only, contact:  Brian J. Gottstein
Email: bgottstein@oag.state.va.us (best contact method)
Phone: 804-786-5874

Sentencing in Abbott Labs Depakote case: Judge approves $1.5 billion settlement to resolve complaints of off-label promotion of drug

~ Virginia-led investigation was largest state Medicaid fraud investigation in U.S. history ~

ABINGDON, VA (October 2, 2012) - As part of the largest Medicaid fraud case ever led by a state, Attorney General Ken Cuccinelli announced the sentencing of global health care company Abbott Laboratories Inc. in the United States District Court in Abingdon, Va., today. The court approved the $1.5 billion settlement reached on May 7, 2012, among Abbott, Virginia, the United States government, and 48 other states and the District of Columbia, in which Abbott pled guilty to a criminal charge and admitted civil liability for the company's unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA). 

The attorney general's Medicaid Fraud Control Unit (MFCU) was the lead investigative agency in the case, partnering with the prosecutors and civil attorneys from the U.S. Attorney's Office for the Western District of Virginia. This was the largest Medicaid fraud recovery in U.S. history resulting from a state-led investigation, with the Virginia MFCU spending more than four years on the investigation, traveling to 26 states to conduct interviews and sifting through more than one million records looking for evidence.

When it pled guilty in May, Abbott agreed to pay $1.5 billion to resolve its criminal and civil liability pertaining to government health care programs that were defrauded based on reimbursements paid for Depakote due to Abbott's illegal marketing practices. The settlement that was approved today includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. The civil settlement includes $270 million for the federal government's share of the Medicaid program; $239 million for the states' share of the Medicaid program; and $291 million for Medicare and other federal programs. Abbott will also pay a $500 million fine to the federal government, $198.5 million in criminal asset forfeiture penalties, and $1.5 million to Virginia MFCU to cover investigative costs. Virginia's share of the Medicaid civil settlement is $4.2 million. 

Abbott must also agree to the terms of a Corporate Integrity Agreement with the Office of the Inspector General for the Department of Health and Human Services.

"I've made fighting Medicaid fraud a priority in Virginia by increasing the size of our fraud team by adding 30 new people over the last two years," said Cuccinelli. "I'm committed to ensuring that money intended for medical services for the poor isn't stolen from them and the taxpayers through fraud. Medicaid dollars are limited, and fraud deprives people in true need of necessary medical care."

He continued, "This settlement will allow 49 states, the District of Columbia, and the federal government to recover money fraudulently taken from Medicaid, Medicare, and other health care programs." Louisiana is pursuing separate litigation.

On May 7, Abbott pled guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved. In an agreed statement of facts filed in the criminal action, Abbott admitted that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.

The FDA is responsible for approving drugs as safe and effective for specified uses. Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a drug. A company's promotional activities must be limited to only the intended uses that are FDA approved. Promotion by the manufacturer for other uses - known as "off-label" uses - renders the product misbranded, and is illegal.

 For more information on the history of the Abbott Labs settlement, please click here.

Virginia's role in the Abbott case

In September 2007, the Virginia attorney general's Medicaid Fraud Control Unit (MFCU) was contacted with allegations of off-label drug marketing by Abbott Pharmaceuticals.

Although neither the whistleblowers nor the defendant in this case were located in Virginia, the whistleblowers came to Virginia because the MFCU has a national reputation for successfully investigating major national cases, such as the Purdue Pharma Oxycontin case, the Octagon case, and others.

Following Virginia MFCU's initial investigation, the unit contacted the U.S. Attorney's Office for the Western District of Virginia because of their history of working together on such cases. They then began a joint investigation.

On October 31, 2007, the first qui tam ("whistleblower") suit was filed in the United States District Court in Abingdon, Va., against Abbott Laboratories for marketing the drug Depakote for off-label uses. Three other qui tam complaints from other relators were subsequently filed.

MFCU investigators operating out of the attorney general's offices in Roanoke and Abingdon were assigned to the investigation full-time and spent more than four years and 38,000 man-hours on the investigation, traveling to 26 states to conduct interviews and sifting through more than one million records looking for evidence.

The investigation uncovered that Abbott illegally marketed Depakote for non-approved uses, including as an alternative to antipsychotics to treat dementia patients in nursing homes, and for schizophrenia. The investigation also revealed that Abbott paid rebates to health care professionals and long-term care pharmacies for increasing their off-label use of Depakote. 

Attorney General Cuccinelli would like to thank Randall "Randy" Clouse, Director and Chief of Health Care Fraud and Elder Abuse section, and the following MFCU investigators and attorneys for their work in this case: Erica Bailey, Mary Blackburn, Steve Buck, Beverly Darby, Harold Erwin, Elizabeth Fitzgerald, William Clay Garrett, Doug Johnson, John Johnston, Kristy Knighton, Adele Neiburg, John Peirce, and Joey Rusek.

Virginia's MFCU: A history of stopping Medicaid fraud

The Virginia MFCU was established in 1982 within the attorney general's office to investigate and prosecute insurance fraud against the federally funded Medicaid program for indigent health services. MFCU employs a professional staff of criminal investigators, auditors, and several assistant attorneys general who are experienced in commercial and financial investigations. MFCU works regularly with federal and state law enforcement agencies, as well as private insurance companies operating within Virginia.

Over the past 30 years, prior to the Abbott case, Virginia's MFCU had recovered nearly $800 million by tracking down and prosecuting Medicaid fraud offenders. This fiscal year alone, MFCU has recovered more than $22 million. MFCU was also involved in the recovery of more than $634 million after a joint criminal investigation revealed that Purdue Pharma Company fraudulently misbranded the drug OxyContin by marketing the drug to physicians as a slower release -- and thus less addictive -- drug than other prescription opioids. 

From 2010 to today, Attorney General Cuccinelli increased the number of Medicaid fraud and elder abuse staff by more than 50 percent (from 56 to 86) to better combat fraud in Virginia's Medicaid program and to protect the elderly from individuals who abuse and neglect them in nursing homes and health care facilities. It is the only section of the office that he has grown significantly during his tenure, while he has maintained a smaller general fund budget allocation than when he came into office.

Mass Attorney General Files Suit Against Ortho-McNeil-Janssen for Illegally Marketing Risperdal

MARTHA COAKLEY
ATTORNEY GENERAL
Press Release
August 01, 2011

BOSTON – Drug manufacturer Ortho-McNeil-Janssen (“Janssen”) is being sued by Attorney General Martha Coakley’s office for illegally marketing Risperdal, an atypical antipsychotic medication. The lawsuit alleges that Janssen promoted the drug to treat elderly dementia and a number of uses in children and adolescents when these uses had not been shown to be safe and effective and had not been approved by the U.S. Food and Drug Administration (“FDA”).

The complaint, filed in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Attorney General Coakley said. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”

According to the Attorney General’s lawsuit, Janssen’s unfair and deceptive practices included:

Omitting and/or concealing material facts regarding Risperdal’s efficacy and safety in its communications with Massachusetts health care providers and consumers;

• Concealing, omitting or minimizing the side effects and risks associated with Risperdal’s use;
• Promoting Risperdal to treat elderly dementia without disclosing to prescribers the serious risks associated with Risperdal’s use in dementia patients, including an increased risk of death;
• Promoting Risperdal to treat elderly dementia without disclosing to prescribers that the U.S. Food & Drug Administration had rejected the company’s request to market Risperdal for this use because of unaddressed safety concerns;
• Promoting Risperdal’s use as safe and effective to treat conduct disorder and other conditions in children for more than a decade before receiving FDA approval to market Risperdal to treat any conditions in children;
• Making misleading and deceptive statements to prescribers about Risperdal’s safety, particularly with respect to weight gain and the risk of developing diabetes;
• Paying physicians to participate in sham consulting programs that were, in fact, thinly disguised marketing programs touting unapproved uses;
• Targeting its sales and marketing efforts to prescribers who rarely, if ever, prescribe Risperdal for its FDA-approved uses, primarily the treatment of schizophrenia and bipolar mood disorder.

Janssen’s illegal marketing and sales tactics helped the company generate hundreds of millions of dollars in sales in the Commonwealth, according to the complaint. Citing company documents, the lawsuit notes that these illegal tactics helped make Risperdal a market leader in both the children and adolescent and elderly market segments.

This matter is being handled by Assistant Attorneys General Sarah Ragland, Wendoly Langlois and Emiliano Mazlen, with assistance from division chief Thomas O’Brien and paralegal Marie Defer, all of the Attorney General Coakley’s Health Care Division.

In Shift, Feds Target Top Execs for Health Fraud

Associated Press
May 31, 2011
WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.
Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.
Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.
Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.
The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.
“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.
“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”
Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.
“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”
Others say high-powered corporate targets won’t go meekly.
“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”
Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.
Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.
A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.
The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”
Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.
The company said it had considered the case closed. But then came the inspector general’s letter.
“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”
Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”
Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.
The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.
It’s making an entire industry nervous.
Read article here: http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

Dr. Angell on the Mental Illness Epidemic

CommonHealth Reform and Reality
WBUR.org
June 9, 2011
Carey Goldberg

I can’t wait for the next issue of The New York Review of Books. It’s slated to carry the second half of a review written by Dr. Marcia Angell of Harvard Medical School, and I’m eager to see how it’s going to come out.

Marcia is the former editor of the New England Journal of Medicine, and from her lofty position at the pinnacle of the medical establishment, she speaks out about the shortcomings of the American health care system and the dangers of financial conflicts of interest in medicine. A 2009 piece of hers in the New York Review of Books, titled “Drug Companies and Doctors: A Story of Corruption,” brought vehement objections in print from Stanford and the American Psychiatric Association, which, in my opinion, she soundly trounced in her response.

Her current review looks at three books, two of which have already been mentioned on CommonHealth: Robert Whitaker’s Anatomy of an Epidemic and Dr. Daniel Carlat’s “Unhinged.” I haven’t read the third yet: Irving Kirsch’s “The Emperor’s New Drugs: Exploding The Antidepressant Myth,” but it sounds like it suggests that antidepressants are largely ineffective, and any positive results they may produce likely stem mainly from the placebo effect.

It’s worth reading the whole review, but here’s a small excerpt:

The authors emphasize different aspects of the epidemic of mental illness. Kirsch is concerned with whether antidepressants work. Whitaker, who has written an angrier book, takes on the entire spectrum of mental illness and asks whether psychoactive drugs create worse problems than they solve. Carlat, who writes more in sorrow than in anger, looks mainly at how his profession has allied itself with, and is manipulated by, the pharmaceutical industry. But despite their differences, all three are in remarkable agreement on some important matters, and they have documented their views well.

First, they agree on the disturbing extent to which the companies that sell psychoactive drugs—through various forms of marketing, both legal and illegal, and what many people would describe as bribery—have come to determine what constitutes a mental illness and how the disorders should be diagnosed and treated. This is a subject to which I’ll return.

Second, none of the three authors subscribes to the popular theory that mental illness is caused by a chemical imbalance in the brain.

Top Ten Legal Drugs Linked to Violence - "Time Mag"

TIME Magazine
Maia Szalavitz
January 7, 2011
When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA's Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.

Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they're used to try to stop it.

Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons. Here are the top ten offenders:

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.
9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior. (More on Time.com: Adderall May Not Make You Smarter, But It Makes You Think You Are)
8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence
7. Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.
6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.
5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.
4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain's dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.
3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs. (More on Time.com: Healthland's Guide to Life 2011)
2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.
1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it's 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. Because Chantix is slightly superior in terms of quit rates in comparison to other drugs, it shouldn't necessarily be ruled out as an option for those trying to quit, however.

Read more: http://healthland.time.com/2011/01/07/top-ten-legal-drugs-linked-to-violence/#ixzz1DHvpV500

Ralph Nader -- The Whistle Has Been Blown, But Where's the Enforcement? Drug Industry Fraud

Counter-Punch
December 28, 2010
By RALPH NADER

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators' campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the "current system of enforcement is not working." He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says "the lack of criminal prosecution that would result in jailing of company executives." is key. Moreover, the report notes that "a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues."

A flicker of hope that a little change is on the way came from the Food and Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: ".unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy--.we can not expect to make progress in deterring off-label promotion."

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

Ralph Nader is the author of Only the Super-Rich Can Save Us!, a novel.

Placebo fraud rocks the very foundation of modern medical science; thousands of clinical trials invalidated

Thursday, October 28, 2010
by Mike Adams, the Health Ranger

(NaturalNews) You know all those thousands of clinical trials conducted over the last few decades comparing pharmaceuticals to placebo pills? Well, it turns out all those studies must now be completely thrown out as utterly non-scientific. And why? Because the placebos used in the studies weren't really placebos at all, rendering the studies scientifically invalid.

This is the conclusion from researchers at the University of California who published their findings in the October issue of the Annals of Internal Medicine. They reviewed 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.

Why is this important? Because placebo pills are supposed to be inert. But nothing is inert, it turns out. Even so-called "sugar pills" contain sugar, obviously. And sugar isn't inert. If you're running a clinical trial on diabetics, testing the effectiveness of a diabetes drug versus a placebo then obviously your clinical trial is going to make the diabetes drug look better than placebo if you use sugar pills as your placebo.

Some placebo pills use olive oil which may actually improve heart health. Other placebo pills use partially-hydrogenated oils which harm heart health. Yet only 8 percent of clinical trials bothered to list the placebo ingredients at all!

Stay with me on this placebo issue... because it gets even more bizarre...

There are no FDA rules regarding placebos in clinical trials

It turns out there are absolutely no FDA rules regarding the choice or composition of placebos used in clinical trials. Technically, a clinical trial director could use eye of newt or lizard's legs as placebo and would not even be required to mention such nefarious details in the trial results. That would cause trouble, trouble, boil and bubble! (Shakespeare reference for all you literary fans...)

We already know that clinical trials are rife with fraud. Most of the clinical trials used by pharmaceutical companies to win FDA approval of their drugs, for example, are funded by pharmaceutical companies. And it is a verifiable fact that most clinical trials tend to find results that favor the financial interests of whatever organization paid for them. So what's to stop Big Pharma from scheming up the perfect placebo that would harm patients just enough to make their own drugs look good by comparison?

Fact: Placebos are usually provided by the very same company funding the clinical trial! Do you detect any room for fraud in this equation?

How drug companies can fake clinical trials with selected placebo pills

Placebo performance strongly influences whether drugs are approved by the FDA, by the way. As the key piece of information on its regulatory approval decisions, the FDA wants to know whether a drug works better than placebo. That's the primary requirement! If they work even 5% better than placebo, they are said to be "efficacious" (meaning they "work"). This is true even if the placebo was selected and used specifically to make the drug look good by comparison.

You see, if there are no regulations or rules regarding placebo, then none of the placebo-controlled clinical trials are scientifically valid.

It's amazing how medical scientists will get rough and tough when attacking homeopathy, touting how their own medicine is "based on the gold standard of scientific evidence!" and yet when it really comes down to it, their scientific evidence is just a jug of quackery mixed with a pinch of wishful thinking and a wisp of pseudoscientific gobbledygook, all framed in the language of scientism by members of the FDA who wouldn't recognize real science if they tripped and fell into a vat full of it.

Big Pharma and the FDA have based their entire system of scientific evidence on a placebo fraud! And if the placebo isn't a placebo, then the scientific evidence isn't scientific.

Oh, but wait. They'll call it science because they wish the placebo to be a placebo. Yep -- the clinical researchers are now psychics, mediums and fortune tellers who simply decree that little pill of olive oil to "be a placebo!" while waving their hands over it in a gesture borrowed from David Copperfield.

James Randi may have never seen a psychic transmute lead into gold, but he's no doubt seen doctors transmute biochemically active substances into totally inert materials merely by wishing them so! It's so amazing!

And this brings me to the really interesting "how-to" part of this article...

How to make your own placebo just like clinical researchers do

Are you wondering how to make your own FDA-approved, scientifically validated placebo? It's easier than you think.

Step 1 - Find something shaped like a pill. It could be a pill full of olive oil, white sugar, palm oil, fluoridated water, chalk dust, synthetic chemicals or just about anything you can imagine.

Step 2 - Close your eyes and get ready to concentrate.

Step 3 - This is the important part - Repeat out loud five times while turning counter-clockwise, "I am a scientific researcher practicing evidence-based medicine!" You must say this until you really, truly believe it. If you don't believe it strongly enough, the placebo effect will be ruined.

Step 4 - Thrust your palm in the direction of the placebo pills and shout, at the top of your voice, "You are now placebo!" You may feel a shiver of energy coursing through your body. That's the power of placebo reaching out to the pills.

The process is now complete. You may now use these placebo pills in any clinical trial and expect full approval of such use by your colleagues, famous medical journals and FDA regulators. (This is not a joke. This is the state of the art today in conventional medicine.)

Hope also has a huge role to place in all this. The more you hope your placebos are really placebos, the better results you'll get. In fact, in reporting on this whole fiasco, the lead researcher of the study uncovering all this, Dr Beatric Golomb, said, "We can only hope that this hasn't seriously systematically affected medical treatment."

But of course it has. (And by the way, no disrespect toward Dr Golomb. She deserves kudos for being willing to tackle this subject which will no doubt make her very unpopular among the cult of Scientism as practiced by conventional medical researchers today.)

How to improve your clinical trial results

For improved results, try to use the most harmful placebo substances you can. For example, in real clinical trials involving AIDS patients -- who tend to be lactose intolerant -- researchers have used pills made of, guess what? Lactose!

That's sort of like running a clinical trial on a cure for heroin addiction and using heroin as the placebo, isn't it? Gee, somehow our drug worked "better than placebo." Funny how that works, isn't it?

And if you still don't get the results you want, just start inventing your own data like other clinical trial researchers do. Remember Dr Scott Reuben? This highly-respected clinical trial researcher faked at least twenty-one clinical trials for Big Pharma (http://www.naturalnews.com/028194_S...). His fraudulent clinical trials are still being cited to sell prescription medications!

Heck, who needs placebo when you can just invent the data?

Come to think of it, who needs science when you can just use anything you want and call it placebo in the first place?

Conventional medicine operates clinical trials in the same way that banks and securities firms handle mortgage documents. They all just sort of make things up as they go along, committing felony crimes on a daily basis while hoping nobody notices. On that note, check out this amazing story by Greg Hunter called The Perfect No-Prosecution Crime (http://usawatchdog.com/the-perfect-...).

Where on the skeptics when it comes to Big Pharma science fraud?

Seriously, you just gotta love the state of medical science today. I've never watched a more hilarious group of nincompoops reassure each other that they're all so scientific while practicing the most quack-ridden chicanery imaginable. The stuff being pulled off today in the name of Big Pharma's clinical trials makes psychic detectives and tarot card readers look downright scientifically gifted by comparison.

It really makes you wonder about so-called "skeptics," doesn't it? If they're skeptical of homeopathy, tarot cards, psychic mediums and people who claim they can levitate, I can at least understand the urge to ask tough questions about all these things. I ask tough questions, too, especially when people tell me they've seen ghosts or spirits coming back from the dead or other unexplained phenomena. (And I've already publicly denounced so-called "psychic surgery" which it quite obviously little more than sleight-of-hand trickery combined with animal blood.)

But most conventional skeptics never step out of bounds of their "safety zone" of popular topics for which skepticism may be safely expressed. They won't dare ask skeptical questions about the quack science backing the pharmaceutical industry, for example. Nor will they ask tough questions about vaccines, or mammography, or chemotherapy. And you'd be hard pressed to find anything more steeped in outright fraudulent quackery than the pharmaceutical industry as operated today (and the cancer branch of it in particular).

That's why I'm skeptical about the skeptics. If a skeptic doesn't question the loosey goosey pseudoscience practiced by Big Pharma, then they really have no credibility as a skeptic. You can't be selectively skeptical about some things but then a fall-for-anything fool on other scams just because they're backed by drug companies.

But getting back to this study in particular...

Abstract of the study

Here's some of the text from the abstract of this study published in the Annals of Internal Medicine (http://www.annals.org/content/153/8...)

What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials

1. Beatrice A. Golomb, MD, PhD;
2. Laura C. Erickson, BS;
3. Sabrina Koperski, BS;
4. Deanna Sack, BS;
5. Murray Enkin, MD; and
6. Jeremy Howick, PhD

Background: No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.

Purpose: To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials.

Data Sources: 4 English-language general and internal medicine journals with high impact factors.

Study Selection: 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009.

Data Extraction: Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus.

Data Synthesis: Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).

Limitation: Journals with high impact factors may not be representative.

Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

Primary Funding Source: University of California Foundation Fund 3929 -- Medical Reasoning.

Former Glaxo Lawyer Charged With Obstruction of Probe

The Wall Street Journal
November 2010
By THOMAS CATAN And PETER LOFTUS

Federal prosecutors charged a former GlaxoSmithKline PLC attorney with lying to obstruct a U.S. investigation into whether the pharmaceutical company illegally marketed an antidepressant as a weight-loss drug.

The Department of Justice on Tuesday indicted Lauren Stevens, a former vice president at the drug company, with four counts of making false statements to the Food and Drug Administration, as well as obstructing its investigation and withholding documents.

The indictment reflects a new U.S. effort to hold company executives legally accountable for criminal wrongdoing, rather than simply fining the companies for violations.

"This indictment shows that we will investigate those responsible for unlawful acts done on a company's behalf," said Richard DesLauriers, a special agent at the Federal Bureau of Investigation.

Ms. Stevens's lawyer said she did nothing wrong.

"Lauren Stevens is an utterly decent and honorable woman," Brien O'Connor said. "Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer."

The indictment didn't identify the company or drug involved, but Glaxo confirmed that Ms Stevens formerly worked in its U.S. legal department and that the investigation involved its antidepressant Wellbutrin SR. It declined to comment further.

In its 2009 annual report, Glaxo disclosed that the government was inquiring about the company's response to an October 2002 letter from the FDA. The letter asked for information on the company's "alleged promotion of Wellbutrin SR for off-label use," meaning a use for which the drug didn't have FDA approval. Antidepressants have at times been associated with weight loss, though also with weight gain.

The U.S. attorney's office in Massachusetts has been leading a long-running investigation into Glaxo's marketing of several products between 1997 and 2004, including Wellbutrin SR, Glaxo has disclosed.

Glaxo first disclosed the existence of the investigation in 2004, and last year said it was taking a $400 million charge in relation to the probe, in a possible sign that it was approaching a settlement.

The Justice Department, acting on behalf of the FDA, has recently reached a slew of recent legal settlements with pharmaceutical companies for various violations, many of them prompted by information from whistleblowers.

Last month, GSK pleaded guilty to charges that it knowingly sold adulterated drugs made at its factory in Puerto Rico, paying $750 million in fines. The previous month, Allergan Inc. pleaded guilty to charges that the company actively promoted its top-selling product, the wrinkle-smoothing drug Botox, for unapproved medical uses such as treating headaches and pain. It paid $600 million to resolved the charges.

No individuals were indicted in those cases. To have an effective deterrent effect, the Justice Department has emphasized that it wishes to prosecute individual executives involved in corporate wrongdoing, so that the fines aren't simply seen as a cost of doing business.

The Wall Street Journal reported in March that the Food and Drug Administration planned to increase prosecutions of industry executives and corporate counsel.

Tuesday's indictment alleged that Ms. Stevens made a series of false statements and deliberately withheld potentially incriminating evidence from investigators. For example, she allegedly decided not to submit presentations made on the company's behalf by doctors who promoted the drug for unapproved purposes, prosecutors said.

A memorandum she requested to help decide whether she should hand over the slide sets warned that such a move would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation," the indictment said.

Instead of providing the slides, Ms. Stevens wrote that the company's responses to the FDA's requests were "final" and "complete." The indictment says a company employee reported the alleged off-label promotion of the drug and sent the FDA some of the missing slides.
—Jeanne Whalen and Alicia Mundy contributed to this article.

Write to Thomas Catan at thomas.catan@wsj.com and Peter Loftus at peter.loftus@dowjones.com

Drug Company to Pay Half a Billion Dollar Fine for ILLEGAL Marketing

Mercola.com
The World's #1 Free Natural Health Newsletter
May 20, 2010

Drugmaker AstraZeneca has agreed to pay $520 million to settle federal investigations into marketing practices for its schizophrenia drug Seroquel. This makes AstraZeneca the fourth big drug company in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs.

The company was accused of misleading doctors and patients by spotlighting favorable research while failing to adequately disclose studies showing that Seroquel increases the risk of diabetes.

The New York Times reports that:

"AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug's risks. "

Sources:
New York Times April 26, 2010
The United States Department of Justice April 27, 2010


Dr. Mercola's Comments:

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The illegal and unsafe actions of drug companies make headlines yet again as AstraZeneca agrees to pay a $502 million fine to settle the federal charges of using illegal marketing tactics to drive up sales of its blockbuster drug Seroquel.

Although this sounds like a lot of money, it's little more than a symbolic slap on the wrist when you consider how much money they've made from the drug already. According to the New York Times, the antipsychotic drug Seroquel pulled in $4.9 BILLION in sales last year!

You see from the company's perspective it's merely another cost of doing business. For every dollar they are fined they are making ten. While not all of their profit was due to their illegal marketing practices, the fine was only a one-time fine, while revenues have poured in over many years and will continue to do so in the future, as a result of these illegal activities.

How Did Potent Antipsychotics Become the Top Selling Drug Category in US?

Amazingly, and something that not even I had realized until this article was being written, is that this class of antipsychotics has now surpassed cholesterol-lowering drugs as the top-selling category of drugs in the US!

This fact, in and of itself, should be a red flag that something has gone seriously awry, because no nation could possibly have that many psychotic residents.

And that's just... We don't.

Using illegal marketing tactics to promote the use of Seroquel and other drugs like it has greatly expanded the sale of these types of drugs for far less serious, and at times completely unrelated, ailments.

Making matters even worse, they've also been heavily promoted for seniors and children - groups in which this drug can be far more dangerous.

Seroquel has been found to cause rapid weight gain and diabetes, for example. And seniors with dementia are at a higher risk of death when taking this drug. These are just a couple of reasons why Seroquel has been unable to gain FDA approval for certain uses. And yet, AstraZeneca, like so many other drug companies, chose to put profits before safety and health once again.

Puny Fines after Making Massive Illegal Profits Seem to Be the Norm

Just last month I discussed the case of Pfizer, the world's largest pharmaceutical company, that was "punished" with a fine that amounted to three month's worth of profit for the illegal marketing of the painkiller Bextra.

In 2005, when Bextra was pulled from the market due to its increased risks of heart attack and stroke, about half of its $1.7 billion in profits that year were due to unapproved off-label uses.

There's no doubt that Seroquel's blockbuster status and massive sales are in large part due to dangerous off-label uses as well.

Seroquel was approved by the FDA in September 1997 for "the treatment of manifestations of psychotic disorders."

Three years, later, the FDA actually considered NARROWING its approval to the short term treatment of schizophrenia only. However, by January, 2004, the drug was approved for the short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania), and two years later, they also approved it for bipolar depression.

Schizophrenia and bipolar disorder are serious mental disorders that in many cases may warrant drug treatment, at least short term. However, AstraZeneca also pushed Seroquel for things like anger management, ADHD, Alzheimer's disease, and even difficulty sleeping!

No federal criminal charges have been filed against the company, but I wonder if that wouldn't be justified. After all, they're promoting a potent drug for diseases that they were never formally studied or approved for.Without this important proof of safety and effectiveness, they have put countless human lives at risk for serious side effects, including premature death.

How is this NOT a crime?

But wait, of course no criminal charges will be filed because, just like Wall Street bankers, these companies are "too big to fail". What a load of horse manure, pardon my language. Nevertheless, that is what happens when your profits are so large you can afford to lobby and payoff the right people in government, to effectively insulate you from any prosecution.

Yes these companies are VERY clever.

Off-Label Use of Drugs Increase Your Risk of Harmful Side Effects

While doctors can legally prescribe FDA-approved medications off-label for any use, drugmakers are not allowed to market them for anything other than approved uses.

Many physicians, however, for all intents and purposes rely nearly exclusively on drug reps to educate them about the indications for drugs and what other leading physicians are using them for, and drug companies are not shy about suggesting off-label uses.

As demonstrated by this recent rash of lawsuits, drugmakers actually go several steps further, by fraudulently manipulating doctors into prescribing their drugs for ailments that they could not gain approval for in the first place.

Complicating matters further is the fact that it can be difficult for physicians to determine what certain medications are approved for, based on the Summary of Product Characteristics (SPC) -- the information given to physicians about drugs.

In fact, according to a 2009 study, it was impossible for physicians to determine the licensing status for about 20 percent of drug... which means it's even more likely they'll rely on drug reps' opinions and suggestions.

Off-label drug use is actually extremely common, for drugs of all kinds.

According to studies conducted in Britain, when a "suitable alternative" did not exist, doctors used unlicensed or "off label" medicine in:

* 90 percent of babies in neonatal intensive care units
* 70 percent of children in pediatric intensive care units
* Two-thirds of children on general medical and surgical pediatric wards in the UK

According to two of the studies, children taking these medicines face a higher risk of side effects, with one estimate suggesting they suffer up to three times more side effects as a result.

This is why it's so important that drug companies refrain from these illegal marketing tactics, because doctors mislead by their pharmaceutical reps are literally putting their patients' lives at risk!

As Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania stated:

"People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In the end that's all it is... Promoting drugs for off-label uses has nothing to do with trying to help more people. It's all about making more money off a drug that has a limited market.

The Dangerous Side Effects of Seroquel

It's hard to believe that anyone would agree to take such a potent antipsychotic unless they were suffering from a serious mental illness, but the numbers prove that plenty of people do.

This choice can be a devastating one. (And remember, it IS a choice. Your doctor cannot force you to take any drug, and in many cases, people see an ad on TV and voluntarily ask for the drug.)

The potential side effects of taking Seroquel are numerous, and some of them can be fatal.

For example, elderly patients who have lost touch with reality as a result of dementia are at an increased risk of death, which is why Seroquel is not approved for this use.

Seroquel can also increase your risk of suicidal thoughts and actions, especially in children, teens and young adults.

It's worth noting that the list of serious side effects is far longer - and these reactions are FAR MORE COMMON - than the list of the non-life threatening adverse reactions.

For example, some of the most common side effects of Seroquel include:

* High triglycerides in 23 percent of patients
* Weight gain in 23 percent of patients
* Agitation in 20 percent of patients
* High cholesterol in 17 percent of patients

Meanwhile, mild side effects like nausea, congestion and stomach pain are far less common, occurring in only two to ten percent of patients.

Be One Less Victim

Fortunately, you can avoid becoming the next victim by taking control of your health. This means educating yourself about your condition, any symptoms you may have, the drugs your doctor recommends, and other alternatives.

I can't stress this enough: You are NOT REQUIRED to take a drug recommended by your doctor.

You ARE allowed to demand detailed answers to any questions you have about the drug prescribed to you, and if you decide that the risks are greater than the potential benefit, you can "just say no," and seek out alternatives.

Remember, this is your life, and your health, so take an active role in it!. If your doctor pressures you to take it, remember that there are other doctors out there and it is probably best to find someone else who will actually LISTEN to you.

Leading a healthy lifestyle and staying educated about drug-free and non-invasive treatment options are the keys to your long-term well-being.

It's unfortunate, but many are still completely unaware of the pervasive corruption that exists within the field of pharmaceuticals. You need to understand that any corporation's primary and essential responsibility is to their shareholders -- NOT to you.

Drug companies have accumulated so much wealth, power and political influence that they're able to escape any serious consequences linking them to profiting from permanently disabling, crippling or even killing consumers. This is why it's so imperative you make your own informed decisions rather than blindly trusting the system.

Physicians must also, en masse, come to the realization that drug reps cannot be trusted. This may be one of the most difficult areas to change, as the pharmaceutical industry has devised a highly effective system of indoctrination and very specific psychological techniques to manipulate physicians.

Doctors usually believe they are immune to persuasion tactics, and drug reps know just how important it is to maintain that illusion -- which is why it works so well. However, the idea that reps provide a valuable, informative service to physicians is total fiction, created and perpetuated by the drug industry, to keep this deadly, but profitable, scheme going.

Until real change takes place, I urge you to not risk your money or your life on a paradigm designed to profit from your ill health.

Instead, take control by adopting natural lifestyle strategies that will promote your body's natural healing abilities without the need for the drug companies' latest creations.

Feds found Pfizer too big to nail

CNN Special Investigations Unit
By Drew Griffin and Andy Segal,
April 2, 2010

CNN's Special Investigations Unit reveals internal company documents on Bextra and Pfizer's health care fraud. Watch at 3 p.m. ET Saturday on CNN.

VIEW VIDEO OF THIS STORY HERE:
www.youtube.com/watch?v=7ehUWAsSvFw

(CNN) -- Imagine being charged with a crime, but an imaginary friend takes the rap for you.

That is essentially what happened when Pfizer, the world's largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.

When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. "It sends a clear message" to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI's Criminal Investigative Division.

But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It's a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.

Big plans for Bextra

The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.

Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.

But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.

Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.

But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe.

Doctors as pitchmen

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.

But an internal marketing plan called for training physicians "to serve as public relations spokespeople."

According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, "They pushed the envelope so far past any reasonable interpretation of the law that it's simply outrageous."

Pfizer's chief compliance officer, Doug Lanker, said that "in a large sales force, successful sales techniques spread quickly," but that top Pfizer executives were not aware of the "significant mis-promotion issue with Bextra" until federal prosecutors began to show them the evidence.

By April 2005, when Bextra was taken off the market, more than half of its $1.7 billion in profits had come from prescriptions written for uses the FDA had rejected.

Too big to nail

But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer's collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.

"We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients," said Lewis Morris of the Department of Health and Human Services.

So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.

The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.

Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.

An imaginary friend

Two years later, with Bextra, the shell company once again pleaded guilty. It was, in effect, Pfizer's imaginary friend stepping up to take the rap.

"It is true that if a company is created to take a criminal plea, but it's just a shell, the impact of an exclusion is minimal or nonexistent," Morris said.

Prosecutors say there was no viable alternative.

"If we prosecute Pfizer, they get excluded," said Mike Loucks, the federal prosecutor who oversaw the investigation. "A lot of the people who work for the company who haven't engaged in criminal activity would get hurt."

Did the punishment fit the crime? Pfizer says yes.

It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected.

It paid a billion dollars more to settle a batch of civil suits -- although it denied wrongdoing -- on allegations that it illegally promoted 12 other drugs.

In all, Pfizer lost the equivalent of three months' profit.

It maintained its ability to do business with the federal government.

Pfizer says it takes responsibility for the illegal promotion of Bextra. "I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one," said Doug Lankler, Pfizer's chief compliance officer.

To prevent it from happening again, Pfizer has set up what it calls "leading-edge" systems to spot signs of illegal promotion by closely monitoring sales reps and tracking prescription sales.

It's not entirely voluntary. Pfizer had to sign a corporate integrity agreement with the Department of Health and Human Services. For the next five years, it requires Pfizer to disclose future payments to doctors and top executives to sign off personally that the company is obeying the law.

Pfizer says the company has learned its lesson.

But after years of overseeing similar cases against other major drug companies, even Loucks, isn't sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large.

"I worry that the money is so great," he said, that dealing with the Department of Justice may be "just of a cost of doing business."

Kin sue Harvard over son's suicide - Allege neglect in health services' drug prescription

Boston Globe
Shelley Murphy
December 4, 2009
Harvard sophomore John Edwards was studying to become a doctor and training for the Boston Marathon in June 2007 when he sought help at the university’s Health Services because he could not study for as many hours as some of his friends.

A nurse practitioner prescribed a drug to treat attention deficit hyperactivity disorder, a condition the overachieving Edwards had never been diagnosed with. Later, she prescribed two powerful antidepressants, Prozac and Wellbutrin, when he began complaining of anxiety, depression, and other side effects. Meanwhile, he was taking a fourth drug for acne, Accutane, that has been linked to suicidal thoughts.

“The Wellbutrin is having the effect that we were seeking . . . but unfortunately I feel like it has canceled out the anxiety-reducing effects of the fluoxetine [Prozac], as recently I’ve been pretty nervous,’’ Edwards wrote in a Nov. 27, 2007, e-mail to the nurse practitioner, Marianne Cannon. “Let me know if I should schedule to come in and meet with you soon, or if I should change the med plan.’’

Cannon replied that she was concerned and told Edwards to schedule an appointment with her. Two days later, Edwards, 19, of Wellesley committed suicide in a bathroom at Harvard Medical School by suffocating himself with a plastic bag.

His father, John B. Edwards II of Wellesley, filed a suit Wednesday in Middlesex Superior Court alleging gross negligence by Cannon; Dr. Georgia Ede, who was the doctor who supervised her; and Harvard College, for causing his son’s wrongful death

Harvard released a statement yesterday, saying, “We understand how difficult it must be for John Edwards’ family to cope with such a tragic loss, but we are confident that the care he received at Harvard University Health Services was thorough and appropriate and he was monitored closely by its physicians and allied health specialists.’’

Lisa G. Arrowood, a Boston attorney who represents Edwards, said, “We’re alleging that the supervising physician in this case did not do her job, which was to supervise the nurse who didn’t have medical training that a physician has. She was writing prescriptions for powerful drugs that were inappropriate in this combination and are associated with an increase of suicide.’’
The US Food and Drug Administration has warned that anyone taking Accutane, Prozac, or Wellbutrin should be monitored closely for suicidal thoughts.

“If a college such as Harvard cannot properly care for somebody like Johnny, I think it’s very concerning who can,’’ Edwards’s father said. “They are leaders in medicine and psychiatry, and it’s just astounding that at a school such as Harvard that something like this could happen.’’
Edwards was class president and valedictorian of Wellesley High School class of 2006 and played on the school’s championship tennis team. His father said he was an A student at Harvard and was conducting stem cell research at Harvard Medical School.

He said he “thought it was bizarre’’ when his son told him he had been prescribed medication for attention deficit disorder, because “he never had an attention issue.’’

The suit accuses Cannon of prescribing Adderall, an amphetamine, which caused Edwards to have chest pains and anxiety, then several months later prescribing Prozac and then Wellbutrin, even though Edwards told her he had taken Prozac when he was younger and experienced “out-of-control feelings.’’

Edwards said his son was upset by a break-up with a girlfriend two months earlier, but there was no indication he contemplated taking his own life. He was training for the marathon and had created a Harvard College Marathon Challenge Web page, with a goal of raising $2,000 for two charities. “In six months, I hope to cross the finish line of the Boston Marathon,’’ Edwards wrote.
His father said he last saw him when he dropped him off at his dorm two days after Thanksgiving. “He seemed to be in a good mood,’’ Edwards said. “I gave him a kiss on the head and hugged him. He hugged me. I told him I loved him and left. He seemed to be fine.’’
Edwards said his son, a guitarist, was planning to perform “High and Dry’’ by Radiohead with a friend at a talent show the night after his death. The show was canceled because of the suicide, then held three months later. His only sister, Julia, now 16, learned the song and played it in his memory.

Edwards said he always hated to run, but after his son’s death he started training and ran the Boston Marathon this year.

“I put some of Johnny’s ashes in my back pocket,’’ Edwards said, his voice cracking. “Together we ran the marathon.’’

Shelley Murphy can be reached at shmurphy@globe.com.
© Copyright 2009 The New York Times Company

CCHR INTERNATIONAL Announces FDA Reported Psychiatric Drug Side Effects Search Engine

PRNEWSWIRE
August 4, 2009

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone

Los Angeles, CA (PRWEB) August 4, 2009 -- For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).

The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.

The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.

The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).

It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.

Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.

The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.

Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as "anecdotal" by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best "signal" event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.

For years the information contained in the FDA's MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR's stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full "informed consent" regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.

The psychiatric drug search engine features a promotional video as well as an instructional video for users on CCHR's newly launched website so they can get the information from the database they are looking for in the shortest amount of time.

About The Citizens Commission on Human Rights:

The Citizens Commission on Human Rights is a mental health watchdog co-founded in 1969 by Professor of Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a non-profit, non political, non-religious organization that has been responsible for more than 100 reforms that help protect patients rights against abuses in the field of mental health. For more information about CCHR go to http://www.cchrint.org

Eli Lilly Ghostwrote Articles to Market Zyprexa, Files Show

Bloomberg News

By Elizabeth Lopatto, Jef Feeley and Margaret Cronin Fisk

June 12 (Bloomberg) -- Eli Lilly & Co. officials wrote medical journal studies about the antipsychotic Zyprexa and then asked doctors to put their names on the articles, a practice called “ghostwriting,” according to unsealed company files.

Lilly employees also compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to documents filed in drug-overpricing suits against the Indianapolis-based company, the largest manufacturer of psychiatric medicines.

Drugmakers’ use of ghostwriters has created “a huge body of medical literature that society can’t trust,” said Carl Elliott, a University of Minnesota bioethicist who has written about the practice.

Lilly sought to make Zyprexa “the number one selling psychotropic in history,” according to a 2000 plan distributed to its product team. The memo was among more than 10,000 pages of internal documents unsealed last month in lawsuits by insurers and pension funds seeking to recoup money spent on the drug. They allege Lilly exaggerated Zyprexa’s effectiveness.

“Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases” there, said Lilly spokeswoman Marni Lemons. “Lilly remains prepared to defend ourselves against all of these allegations in the appropriate venue, a court of law.”

FDA Rules

The U.S. Food and Drug Administration doesn’t have a guidance document or regulations specific to ghostwriting, said Karen Riley, an agency spokeswoman.

Lemons declined to answer specific questions about ghostwriting. There is no evidence in the unsealed documents that doctors were paid to sign off on the ghostwritten items.

“We believe these documents describe the marketing of a widely promoted and powerfully dangerous psychotropic medication,” said Thomas Sobol, lead attorney for the insurance plans. “Transparency is critically important.”

Lilly isn’t the only drugmaker to use ghostwriters to win favorable play in medical journals. Merck & Co. and Pfizer Inc. also have faced claims they used ghostwriters as part of their marketing plans.

In May 2008, Whitehouse Station, New Jersey-based Merck agreed to pay $58 million to 29 states and to stop ghostwriting articles to resolve claims that its advertisements for the withdrawn painkiller Vioxx hid the drug’s health risks.

Improper Marketing

Employees at Merck worked alone or with publishing firms to write manuscripts on Vioxx that were published under the names of academic medical experts, according to an analysis published in the Journal of the American Medical Association in April 2008. Merck pulled Vioxx from the market in 2004.

Pfizer paid $60 million to 33 states in October to settle claims it improperly marketed its Bextra and Celebrex pain relievers. New York-based Pfizer agreed to halt off-label marketing of the medicines and stop ghostwriting about them. It withdrew Bextra in April 2005. Celebrex is still on the market.

“Every company, to some degree, has probably engaged in ghostwriting,” said Joseph Ross, an assistant professor at Mount Sinai School of Medicine in New York and the author of the JAMA paper on Merck’s ghostwriting practices. “It’s a challenging thing to discover without litigation, since it’s mutually beneficial to physicians and people within the industry to keep it under wraps.”

Untrustworthy

In 1996, Wyeth hired Excerpta Medica Inc., a New Jersey- based medical communications firm, to write 10 articles promoting drugs aimed at treating obesity, Elliott wrote in “Ghost Marketing: Pharmaceutical Companies and Ghostwritten Journal Articles,” published in 2007 in the journal Perspectives in Biology and Medicine.

Wyeth, which at the time was touting its fen-phen diet combination for weight loss, agreed to pay Excerpta $20,000 per article, according to Elliott.

“Wyeth kept each article under tight control, scrubbing drafts of any material that could damage sales,” he wrote. Pfizer is acquiring Madison, New Jersey-based Wyeth for $68 billion in cash and stock.

Doug Petkus, a spokesman for Wyeth, declined to immediately comment.

Antipsychotics have become the U.S.’s best-selling class of drugs, with 2008 sales of $14.6 billion, according to IMS Health, a health-care consulting firm.

The insurers suing Lilly contend it should pay as much as $6.8 billion in damages for downplaying Zyprexa’s health risks and marketing the drug for unapproved uses to increase profits.

Top Selling

The antipsychotic is Lilly’s top-selling drug, with $4.7 billion in sales last year, accounting for almost a quarter of the company’s revenue. Lilly officials said in 2002 they sought to boost Zyprexa sales to $6 billion within four years, according to a document unsealed in the insurers’ case. Bloomberg News obtained the documents after U.S. District Judge Jack Weinstein in Brooklyn, New York, made them public on May 1. In September, Weinstein allowed insurers and other payers to sue Lilly as a group after finding “sufficient evidence of fraud” to let the case go to trial. Lilly appealed that ruling.

Lilly agreed in January to pay $1.42 billion to the U.S. government and more than 30 states to settle off-label marketing allegations over Zyprexa. The agreement included a $615 million penalty for a federal criminal charge of illegally marketing the drug to elderly patients for off-label uses.

The company also faces suits from 12 states over its Zyprexa marketing practices. Cases brought by South Carolina and Connecticut officials are set for trial later this year.

Positive Light

The unsealed documents support the claims of the insurers suing Lilly, said Sobol, of Seattle-based Hagens Berman Sobol Shapiro LLP. His firm provided Bloomberg News with copies of the internal papers. Bloomberg News filed a letter brief asking the court to unseal the documents.

Ensuring that medical journal articles presented Zyprexa study results in a positive light was one way for Lilly to reach its sales goal, company officials said in its plan, according to the documents.

To do that, Lilly officials hired ghostwriters to prepare submissions to journals such as Progress in Neurology and Psychiatry, according to the unsealed documents.

“The paper for the Progress in Neurology and Psychiatry supplement has been completed and sent to the journal for peer review,” Kerrie Mitchell, an employee of the public relations agency Cohn & Wolfe, wrote in a Feb. 23, 2001, e-mail to Michael Sale, a Lilly marketing official. The message was among the unsealed files.

“We ‘ghost’ wrote this article and then worked with author Dr. Haddad to work up the final copy,” Mitchell said in the e- mail. Eric Litchfield, a spokesman for Cohn & Wolfe, didn’t immediately return a call seeking comment.

Draft Approved

Peter Haddad, a researcher at Greater Manchester West Mental Health NHS Foundation Trust in the U.K., was listed as the article’s lead author. Haddad didn’t respond to requests for comment.

The global Lilly team approved a draft of Haddad’s ghost- written paper in 2000, according to the unsealed documents. Lilly’s U.K. team had to give final approval to the article because Progress in Neurology and Psychiatry was based there, Mitchell said in the February 2001 e-mail.

Ghostwriter’s Guide

To ensure that ghostwritten Zyprexa articles met Lilly’s standards, company officials issued a guide to preparing them, according to the unsealed files.

The guide, “Medical Press: Pre-Launch Feature Outline,” was undated. It’s unclear from the documents which teams in Lilly’s top 10 markets for the drug received it.

The primer provided a how-to for writing articles, such as instructing the author to use Zyprexa’s generic name, olanzapine, instead of its brand moniker, according to the documents. Scientists in medical research traditionally refer to a drug’s chemical name.

The guide also offered tips on how to find authors by identifying a “key opinion leader” and providing them either an outline of the article or a finished copy. Authors could include a study investigator, an advisory board member or “Lilly-friendly” doctor, according to the documents.

A sample article laid out how a Lilly employee may find a doctor to ghostwrite a submission that would “prepare the market” for the launch of an intramuscular injectable version of the drug. It also offered an outline for the contents of the article, beginning with background on another drug, droperidol, which had been withdrawn from several countries.

The Article

The article, with the suggested title “Filling the Droperidol Gap,” noted that an anti-anxiety drug could be used, before going on to say, “more advanced IM treatments may soon be available to provide a superior alternative.” The article explained that injectable Zyprexa had just received approval from the FDA, and recounted its clinical trial history.

“The anticipated forthcoming availability of atypical antipsychotics in an IM formulation could be a major step forward in the treatment of acute agitation associated with schizophrenia,” the sample article concluded.

Lilly officials e-mailed journal editors to complain about delays in publishing favorable Zyprexa articles, according to the unsealed documents.

In one instance, Lilly employees contacted the Journal of Clinical Epidemiology about delays of an article criticizing a previously published piece linking Zyprexa, as well as the class of atypical antipsychotics, to diabetes.

E-Mail Exchange

After Suraja Roychowdhury, Lilly’s senior scientific communications coordinator, wrote to the journal in November 2002, its editor, Andre Knottnerus, replied in an e-mail that it was “a bit strange to be contacted via the Lilly product team. “Dr. Buse and coauthors can contact us directly next time.”

Knottnerus was referring to the manuscript’s lead author, John Buse, a former president of the American Diabetes Association. A copy of the Nov. 22, 2002, e-mail was included in the unsealed documents.

Patrizia Cavazzoni, a Lilly staffer who co-wrote the article, e-mailed Buse on Jan. 9, 2003, seeking permission to send a separate e-mail asking to expedite publication. She also asked Buse if he would prefer “to send it in your name?”

It isn’t clear from the e-mail chain whether the e-mail was sent by Buse or Cavazzoni. On Jan. 22, 2003, Buse e-mailed Cavazzoni to say he hadn’t heard anything and to request Knottnerus’s telephone number, according to the documents.

The Zyprexa article by Buse and Cavazzoni was a review of another submission that had previously appeared in the journal, according to the documents. That article summarized previous medical literature on atypical antipsychotics, and found Zyprexa had an increased risk of causing diabetes relative to the class.

Toned Down

Buse, a professor of medicine at the University of North Carolina, Chapel Hill, e-mailed his comments on the article to Cavazzoni for her review on Jan. 26, 2003.

Buse indicated in the e-mail that he was worried he had been “unduly harsh” in his review of the earlier piece. He told Cavazzoni: “If you think I should tone it down, suggest a way,” according to the unsealed documents.

There was no response to the e-mail in the documents.

“I don’t remember anybody at Lilly ever approaching me for ghostwriting,” Buse said in a phone interview. Throughout his career, others had offered to put his name on papers, and he declined, Buse said. He said he couldn’t recall the names of anyone involved.

“Ghostwriting used to be quite common,” Buse said. “Now I think it’s uncommon. I’ve been at meetings where clinical trials are being completed and there’s a discussion of who’s going to write which papers, and it’s quite clear everyone’s sensitive to this issue.”

Long Period

Buse said in a Nov. 28, 2006, deposition that working with drugmakers over a long period of time can change the way doctors think about clinical problems.

“It’s sort of like Stockholm Syndrome,” Buse said in the deposition, referring to a psychological phenomenon in which kidnap victims begin to sympathize with their captors.

“I’m not saying that the pharmaceutical industry captures me,” Buse said. “But to the extent that the relationship has something above and beyond medicine, science, you know, it could cloud one’s judgment.”

Buse added that many researchers develop emotional attachments to drugs they’ve discovered or studied extensively.

‘Natural Tendency’

“There’s this natural tendency for people to fall in love with your drug: it’s like your child,” Buse said. “So you have a hard time accepting criticism.”

Barton Moffatt, a Mississippi State University bioethicist who has written about ghostwriting practices among drugmakers, said there’s a growing consensus that doctors who lend their names to such articles are engaging in “academic misconduct.”

“No one has been fired yet over this, but I think the trend is moving in that direction,” Moffatt said. “I think over the last 15 to 20 years, putting your name on a ghostwritten article has come to be seen as plagiarism.”

Lilly rose 47 cents, or 1.4 percent, to $34.38 in New York Stock Exchange composite trading yesterday. The shares have fallen 15 percent this year.

The case is UFCW Local 1776 and Participating Employers Health and Welfare Fund v. Eli Lilly & Co., 05-04115, U.S. District Court, Eastern District of New York (Brooklyn).