Wednesday, January 9, 2013

Newtown, Psychiatric Drug Connection to Mass Murders not covered

World News Daily
NEWTOWN MASSACRE
The giant, gaping hole in Sandy Hook reporting
Exclusive: David Kupelian

January 6, 2013


Since last month’s horrifying and heartbreaking school massacre in Newtown, Conn., politicians and the press have, as everyone knows, been totally obsessed with firearms.

Indeed, President Obama has vowed to impose strong new gun-control measures on the nation – very soon, with or without Congress.

Other possible factors – from violent video games to the “failure of our mental-health system” to the unintended consequences of making schools “gun-free zones” – have taken a back seat to guns. Within hours of the gruesome mega-crime, the media had provided extensive, round-the-clock coverage of precisely which firearms, manufacturers and calibers the perpetrator had used, how he had obtained them from his mother, where they were originally purchased, and so on.

But where, I’d like to ask my colleagues in the media, is the reporting about the psychiatric medications the perpetrator – who had been under treatment for mental-health problems – may have been taking? After all, Mark and Louise Tambascio, family friends of the shooter and his mother, were interviewed on CBS’ “60 Minutes,” during which Louise Tambascio told correspondent Scott Pelley: “I know he was on medication and everything, but she homeschooled him at home cause he couldn’t deal with the school classes sometimes, so she just homeschooled Adam at home. And that was her life.” And here, Tambascio tells ABC News, “I knew he was on medication, but that’s all I know.”

It has been more than three weeks since the shooting. We know all about the guns he used, but what “medication” may he have used? (One brief mini-hoax emerged when the New York Daily News published a story claiming the shooter, according to his uncle, had been on the controversial antipsychotic drug Fanapt. That story was quickly withdrawn after the “uncle” turned out to be a fraudster with no relation to the murderer.)

So, what is the truth? Where is the journalistic curiosity? Where is the follow-up? Where is the police report, the medical examiner’s report, the interviews with his doctor and others?

Get autographed copies of both of David Kupelian’s classics: “The Marketing of Evil” and “How Evil Works.”

But let me back up. Perhaps you’re wondering why this issue of psychiatric medications should be so important.

As I documented in “How Evil Works,” it is simply indisputable that most perpetrators of school shootings and similar mass murders in our modern era were either on – or just recently coming off of – psychiatric medications:

    Columbine mass-killer Eric Harris was taking Luvox – like Prozac, Paxil, Zoloft, Effexor and many others, a modern and widely prescribed type of antidepressant drug called selective serotonin reuptake inhibitors, or SSRIs. Harris and fellow student Dylan Klebold went on a hellish school shooting rampage in 1999 during which they killed 12 students and a teacher and wounded 24 others before turning their guns on themselves.Luvox manufacturer Solvay Pharmaceuticals concedes that during short-term controlled clinical trials, 4 percent of children and youth taking Luvox – that’s 1 in 25 – developed mania, a dangerous and violence-prone mental derangement characterized by extreme excitement and delusion.

    Patrick Purdy went on a schoolyard shooting rampage in Stockton, Calif., in 1989, which became the catalyst for the original legislative frenzy to ban “semiautomatic assault weapons” in California and the nation. The 25-year-old Purdy, who murdered five children and wounded 30, had been on Amitriptyline, an antidepressant, as well as the antipsychotic drug Thorazine.

    Kip Kinkel, 15, murdered his parents in 1998 and the next day went to his school, Thurston High in Springfield, Ore., and opened fire on his classmates, killing two and wounding 22 others. He had been prescribed both Prozac and Ritalin.

    In 1988, 31-year-old Laurie Dann went on a shooting rampage in a second-grade classroom in Winnetka, Ill., killing one child and wounding six. She had been taking the antidepressant Anafranil as well as Lithium, long used to treat mania.

    In Paducah, Ky., in late 1997, 14-year-old Michael Carneal, son of a prominent attorney, traveled to Heath High School and started shooting students in a prayer meeting taking place in the school’s lobby, killing three and leaving another paralyzed. Carneal reportedly was on Ritalin.

    In 2005, 16-year-old Native American Jeff Weise, living on Minnesota’s Red Lake Indian Reservation, shot and killed nine people and wounded five others before killing himself. Weise had been taking Prozac.
    In another famous case, 47-year-old Joseph T. Wesbecker, just a month after he began taking Prozac in 1989, shot 20 workers at Standard Gravure Corp. in Louisville, Ky., killing nine. Prozac-maker Eli Lilly later settled a lawsuit brought by survivors.

    Kurt Danysh, 18, shot his own father to death in 1996, a little more than two weeks after starting on Prozac. Danysh’s description of own his mental-emotional state at the time of the murder is chilling: “I didn’t realize I did it until after it was done,” Danysh said. “This might sound weird, but it felt like I had no control of what I was doing, like I was left there just holding a gun.”

    John Hinckley, age 25, took four Valium two hours before shooting and almost killing President Ronald Reagan in 1981. In the assassination attempt, Hinckley also wounded press secretary James Brady, Secret Service agent Timothy McCarthy and policeman Thomas Delahanty.

    Andrea Yates, in one of the most heartrending crimes in modern history, drowned all five of her children – aged 7 years down to 6 months – in a bathtub. Insisting inner voices commanded her to kill her children, she had become increasingly psychotic over the course of several years. At her 2006 murder re-trial (after a 2002 guilty verdict was overturned on appeal), Yates’ longtime friend Debbie Holmes testified: “She asked me if I thought Satan could read her mind and if I believed in demon possession.” And Dr. George Ringholz, after evaluating Yates for two days, recounted an experience she had after the birth of her first child: “What she described was feeling a presence … Satan … telling her to take a knife and stab her son Noah,” Ringholz said, adding that Yates’ delusion at the time of the bathtub murders was not only that she had to kill her children to save them, but that Satan had entered her and that she had to be executed in order to kill Satan.Yates had been taking the antidepressant Effexor. In November 2005, more than four years after Yates drowned her children, Effexor manufacturer Wyeth Pharmaceuticals quietly added “homicidal ideation” to the drug’s list of “rare adverse events.” The Medical Accountability Network, a private nonprofit focused on medical ethics issues, publicly criticized Wyeth, saying Effexor’s “homicidal ideation” risk wasn’t well-publicized and that Wyeth failed to send letters to doctors or issue warning labels announcing the change.And what exactly does “rare” mean in the phrase “rare adverse events”? The FDA defines it as occurring in less than one in 1,000 people. But since that same year 19.2 million prescriptions for Effexor were filled in the U.S., statistically that means thousands of Americans might experience “homicidal ideation” – murderous thoughts – as a result of taking just this one brand of antidepressant drug.Effexor is Wyeth’s best-selling drug, by the way, which in one recent year brought in over $3 billion in sales, accounting for almost a fifth of the company’s annual revenues.

    One more case is instructive, that of 12-year-old Christopher Pittman, who struggled in court to explain why he murdered his grandparents, who had provided the only love and stability he’d ever known in his turbulent life. “When I was lying in my bed that night,” he testified, “I couldn’t sleep because my voice in my head kept echoing through my mind telling me to kill them.” Christopher had been angry with his grandfather, who had disciplined him earlier that day for hurting another student during a fight on the school bus. So later that night, he shot both of his grandparents in the head with a .410 shotgun as they slept and then burned down their South Carolina home, where he had lived with them.”I got up, got the gun, and I went upstairs and I pulled the trigger,” he recalled. “Through the whole thing, it was like watching your favorite TV show. You know what is going to happen, but you can’t do anything to stop it.”Pittman’s lawyers would later argue that the boy had been a victim of “involuntary intoxication,” since his doctors had him taking the antidepressants Paxil and Zoloft just prior to the murders.Paxil’s known “adverse drug reactions” – according to the drug’s FDA-approved label – include “mania,” “insomnia,” “anxiety,” “agitation,” “confusion,” “amnesia,” “depression,” “paranoid reaction,” “psychosis,” “hostility,” “delirium,” “hallucinations,” “abnormal thinking,” “depersonalization” and “lack of emotion,” among others.The preceding examples are only a few of the best-known offenders who had been taking prescribed psychiatric drugs before committing their violent crimes – there are many others.Whether we like to admit it or not, it is undeniable that when certain people living on the edge of sanity take psychiatric medications, those drugs can – and occasionally do – push them over the edge into violent madness. Remember, every single SSRI antidepressant sold in the United States of America today, no matter what brand or manufacturer, bears a “black box” FDA warning label – the government’s most serious drug warning – of “increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24.” Common sense tells us that where there are suicidal thoughts – especially in a very, very angry person – homicidal thoughts may not be far behind. Indeed, the mass shooters we are describing often take their own lives when the police show up, having planned their suicide ahead of time.

    So, what ‘medication’ was Lanza on?

    The Sandy Hook school massacre, we are constantly reminded, was the “second-worst school shooting in U.S. history.” Let’s briefly revisit the worst, Virginia Tech, because it provides an important lesson for us. One would think, in light of the stunning correlation between psych meds and mass murders, that it would be considered critical to establish definitively whether the Virginia Tech murderer of 32 people, student Cho Seung-Hui, had been taking psychiatric drugs.

    Yet, more than five years later, the answer to that question remains a mystery.

    Even though initially the New York Times reported, “officials said prescription medications related to the treatment of psychological problems had been found among Mr. Cho’s effects,” and the killer’s roommate, Joseph Aust, had told the Richmond Times-Dispatch that Cho’s routine each morning had included taking prescription drugs, the state’s toxicology report released two months later said “no prescription drugs or toxic substances were found in Cho Seung-Hui.”

    Perhaps so, but one of the most notoriously unstable and unpredictable times for users of SSRI antidepressants is the period shortly after they’ve stopped taking them, during which time the substance may not be detectable in the body.

    What kind of meds might Cho have been taking – or recently have stopped taking? Curiously, despite an exhaustive investigation by the Commonwealth of Virginia which disclosed that Cho had taken Paxil for a year in 1999, specifics on what meds he was taking prior to the Virginia Tech massacre have remained elusive. The final 20,000-word report manages to omit any conclusive information about the all-important issue of Cho’s medications during the period of the mass shooting.

    To add to the drama, it wasn’t until two years after the state’s in-depth report was issued that, as disclosed in an Aug. 19, 2009, ABC News report, some of Cho’s long-missing mental health records were located:

        The records released today were discovered to be missing during a Virginia panel’s August 2007 investigation four-and-a-half months after the massacre.

        The notes were recovered last month from the home of Dr. Robert Miller, the former director of the counseling center, who says he inadvertently packed Cho’s file into boxes of personal belongings when he left the center in February 2006. Until the July 2009 discovery of the documents, Miller said he had no idea he had the records.

        Miller has since been let go from the university.

    Although Cho’s newly discovered mental-health files reportedly revealed nothing further about his medications, the issues raised by the initial accounts – including the “officials” cited by the New York Times and the Richmond paper’s eyewitness account of daily meds-taking – remain unaddressed to this day.

    Some critics suggest these official omissions are motivated by a desire to protect the drug companies from ruinous product liability claims. Indeed, pharmaceutical manufacturers are nervous about lawsuits over the “rare adverse effects” of their mood-altering medications. To avoid costly settlements and public relations catastrophes – such as when GlaxoSmithKline was ordered to pay $6.4 million to the family of 60-year-old Donald Schnell who murdered his wife, daughter and granddaughter in a fit of rage shortly after starting on Paxil – drug companies’ legal teams have quietly and skillfully settled hundreds of cases out-of-court, shelling out hundreds of millions of dollars to plaintiffs. Pharmaceutical giant Eli Lilly fought scores of legal claims against Prozac in this way, settling for cash before the complaint could go to court while stipulating that the settlement remain secret – and then claiming it had never lost a Prozac lawsuit.

    All of which is, once again, to respectfully but urgently ask the question: When on earth are we going to find out if the perpetrator of the Sandy Hook school massacre, like so many other mass shooters, had been taking psychiatric drugs?

    In the end, it may well turn out that knowing what kinds of guns he used isn’t nearly as important as what kind of drugs he used.

    That is, assuming we ever find out.

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Wednesday, July 8, 2009

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).

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