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.

Beware pf ghost(writer)s of medical research, Well placed journal articles sell more pills than sales staff do

Straight Goods News
by Dr. Marc Andre Gagnon and Dr. Sergio Sismondo
June 28, 2011

The medical research world has been concerned about the problem of ghostwriting for more than a decade. The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

Big Pharma firms spend twice as much on promotion as on research and development (R&D).
But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

Big Pharma firms spend twice as much on promotion as on research and development (R&D). Worse, more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry's external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals. Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck's Vioxx, GlaxoSmithKline's Paxil, Astra-Zeneca's Seroquel, and Wyeth's hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key articles did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck — the Australasian Journal of Joint and Bone Medicine — and perhaps 10 other fake journals for Merck and other Big Pharma companies.
In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called "Case Study Publication for Peer-Review", or CASPPER, a playful reference to the "friendly ghost". Such strategies are not exceptions; they are now the norm in the industry.

Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies' capacity to influence medical knowledge and create market share and market niches for their products.
In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive. Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebos, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights — and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.
Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck's internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of "rogue" researchers who needed to be "discredited" or "neutralized" — "seek them out and destroy them where they live," reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones — and sometimes through outright fraud. As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

Dr Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr Sergio Sismondo is professor of Philosophy and Sociology at Queen's University. His current research is on the pharmaceutical industry's relationships with academic medicine and practicing physicians.

This article previously appeared in Troy Media.

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

Former Glaxo Lawyer Charged With Obstruction of Probe

Former Glaxo Lawyer Charged With Obstruction of Probe


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 Maker Wrote Book Under 2 Doctors Names, Documents Say

New York Times
By DUFF WILSON
November 29, 2010


Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.


But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.”

The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.

“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

The book has never been in wide circulation and has not been sold for a few years. Guidelines restricting the use of industry money to support medical journal articles or doctors’ research have come into wide acceptance within the last several years, to try to minimize the influence of companies’ marketing on medical practices.

The book’s listed co-authors were Dr. Charles B. Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009 and Emory University before that, and Dr. Alan F. Schatzberg, who was chairman of psychiatry at the Stanford University School of Medicine from 1991 until last year.

The letter documenting the relationship between Dr. Nemeroff, a writing company and SmithKline was dated Feb. 4, 1997. It and a “preliminary draft” of the book, dated Feb. 21, 1997, and adding Dr. Schatzberg’s name were released Monday by the Project on Government Oversight, a Washington advocacy group. They were attached to a letter of complaint to Dr. Francis S. Collins, director of the National Institutes of Health. In the letter, Danielle Brian, executive director of the project, and Paul Thacker, an investigator, formerly with the staff of Senator Charles Grassley of Iowa, also cited other examples of what they termed ghostwriting and asked the N.I.H. for better policing of such practices.

The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.

Responding to questions by e-mail last week, Dr. Nemeroff and Dr. Schatzberg emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work. SmithKline “had no involvement in content,” Dr. Schatzberg said, adding, “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.”

Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”

But the writing company, Scientific Therapeutics Information of Springfield, N.J., had developed “a complete content outline” for Dr. Nemeroff’s comment, according to the 1997 letter from one of the company’s officials. The company also said it had “begun development of the text.” The writing company did not respond to requests for comment.

Kevin G. Colgan, a spokesman for GlaxoSmithKline, said the company’s role in the book was described in its preface. In recent years, he added, the company has tightened its internal guidelines for medical writers.

Ron McMillen, chief executive of American Psychiatric Publishing, which published the book, said he reviewed files on it Monday and found no evidence of influence by the writing company or GlaxoSmithKline. But Mr. McMillen also said he had been unaware of the plan outlined in the two-page letter to Dr. Nemeroff.

“This would show more involvement than we would accept,” he said after reviewing it.

The book sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon, Mr. McMillen said. The authors together received a 15 percent royalty of the $120,000 sales, or about $18,000, he said.

Since there are about 100,000 family physicians in the United States, the book reached only a small percentage of them and has probably declined in usage since 1999. Dr. Howard A. Brody, an author, blogger and professor of family medicine at the University of Texas Medical Branch at Galveston, speculated that family doctors may have had some resistance to a book from a psychiatric press.

Mr. McMillen said the book was co-published with the American Medical Association. He said it was distributed until a few years ago.

Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. “Remarkably, the book remains quite accurate and relevant to clinical practice today,” he said.

Dr. Nemeroff said he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.

Dr. Schatzberg said he had not seen the 1997 letter to Dr. Nemeroff. He termed it “a theoretical proposal that bears little, if any relationship to what actually happened.”

Dr. Lo, who is a professor of medicine and director of the medical ethics program at the University of California, San Francisco, said that medical textbooks and handbooks should make it clear — as peer-reviewed journals now do — whose idea it was, who wrote the first draft, and who edited. Dr. Lo and other experts said ghostwriting has receded in recent years with tougher journal standards.

Dr. Nemeroff and Dr. Schatzberg have been listed on other titles, including co-editors of the Textbook of Psychopharmacology, a book for psychiatrists and medical students, whose third edition appeared in 2003. In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving N.I.H. grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline.

This article has been revised to reflect the following correction:

Correction: December 1, 2010

An article on Tuesday about a drug maker’s involvement in writing a 1999 book that teaches family doctors how to treat psychiatric disorders misstated, in some editions, part of the curriculum vitae of Dr. Charles B. Nemeroff, one of the doctors whose names appeared as authors of the volume. He was once a psychiatry professor at Emory University, not Tulane University.
A version of this article appeared in print on November 30, 2010, on page B3 of the New York edition.

Glaxo to Shift Away from Antidepressant Research CEO admits antidepressant research only based on subjective mood surveys

Wall Street Journal
By Jeanne Whalen
February 5, 2010

GlaxoSmithKline PLC said it will stop research into new antidepressants and focus on diseases for which it believes it can develop more valuable drugs, a major shift for a company that developed some of the biggest-selling antidepressants of the past 20 years.

Profits at the U.K. drug giant, which posted a 66% increase in fourth-quarter earnings Thursday, were long fueled by the antidepressants Paxil and Wellbutrin, which at their peak generated billions of dollars a year in sales. Similar medicines, such as Eli Lilly & Co.’s Prozac and Pfizer Inc.’s Zoloft, also generated big sales for those companies.

However, low-cost generic copies have eroded demand for name-brand antidepressants, which accounted for just 2.3% of Glaxo’s total sales last year, down from 14% in 2002. Chief Executive Andrew Witty said Thursday that the company thinks further investment in the market wouldn’t be prudent.

Part of the reason is financial risk. Clinical trials of antidepressants are among the “most expensive and highest-risk” of all drug trials, Mr. Witty said, because companies often don’t know until the end of very large studies whether a drug works. It is also hard to prove that a depression drug is working, he said, because patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.

That’s a drawback in an era when insurers and other health-care payers want to see clear value for their money, Mr. Witty said.

Payers “want big benefits to make it worth their while to invest their resources,” he said, adding that Glaxo would scrap research into pain drugs for the same reasons, focusing instead on diseases including Alzheimer’s, Parkinson’s, multiple sclerosis and a clutch of rare diseases.

$2.5M verdict over birth defects blamed on Paxil

Associated Press
By MARYCLAIRE DALE (AP)
October 14, 2009

PHILADELPHIA — A jury ordered GlaxoSmithKline to pay $2.5 million to a woman whose son was born with serious heart defects after she took the antidepressant Paxil during her pregnancy.

The closely watched verdict handed down Tuesday in Philadelphia was the first of about 600 similar cases pending across the country that blame Paxil for heart problems and other birth defects.

The jury found GlaxoSmithKline guilty of negligence but not outrageous conduct, and rejected punitive damages. The company vowed to appeal.

"The adverse events started to come in the late 1990s, early 2000. The evidence was overwhelming and alarming," said lawyer Jamie Sheller, who represented plaintiff Michelle David. "They could have known this way, way before they did, way before they changed the label in 2005."

Paxil was classified as a drug with no known link to increased birth defects from its introduction in 1992 through 2005. The Food and Drug Administration began warning in September 2005 that Paxil may be associated with birth defects and strengthened the warning four months later.

David, 28, of Bensalem delivered her full-term son, Lyam Kilker, in October 2005.

He was diagnosed with heart defects two months later and spent five months in a Philadelphia hospital, undergoing surgery to repair two holes in his heart, lawyer Jamie Sheller said Wednesday. He also has a third, separate heart defect and will need at least one more surgery as he grows, she said.

David, a dance teacher and former Philadelphia 76er cheerleader, has no history of heart defects in her family, her lawyer said.

GlaxoSmithKline argues that birth defects occur in 3 to 5 percent of all live births, whether or not the mother took medication during pregnancy.

"The scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition," the drugmaker said in a statement. "Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine's labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

Plaintiffs lawyers will continue to pursue punitive damages in the hundreds of remaining cases, the next of which is set for trial in Philadelphia in November.

"We're starting to chip away at this story, but even as we speak, we're still fighting them, documents are still being produced, depositions are still being taken," Sheller said.

Sales of Paxil totaled $849 million last year.

Paxil has competed fiercely in the marketplace at times with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. The drug no longer has patent protection and now competes against cheaper generic versions.

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