Posts Tagged ‘ghostwriting’

Are You Taking Pills You Don’t Need? Here Are Some Reasons Why

Thursday, July 21st, 2011

OpEdNews – July 21, 2011
by Martha Rosenberg

Most people blame direct-to-consumer advertising, especially on TV, for elevating everyday anxiety to depression, depression to bipolar disorder, childhood behavior problems to psychiatric illnesses, lack of sleep to excessive sleepiness, migraines to epilepsy drug deficiencies and old age to hormone deficiencya.

But ghostwriting also helps the national malaise of people suffering from and treating diseases that didn’t even exist before and ballooning government and private health plans costs.

There are 200 US medical education and communication companies (MECCs) who ghostwrite medical journal articles for pharma for $20,000 to $40,000 per article. Companies like Complete Healthcare Communications (CHC) whose phalanx of 50 medical writers, editors and medical directors promise a “84.5 percent acceptance rate for first-time manuscript submissions.”

Ghostwriting was behind the blockbuster Vioxx, withdrawn in 2004 for doubling the risk of heart attacks. “Merck designed the trial, paid for the trial, ran the trial,” Dr. Jeffrey R. Lisse told the New York Times about a Vioxx study he authored in the Annals of Internal Medicine that left out three cardiac deaths. Oops. “Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then it was sent to me for editing.”

Medical journals themselves can make $450,000 off one such ghostwritten article, because pharma orders reprints which reps disseminate as sales pieces (“look, Doc, it says RIGHT HERE”).

Click image to watch Psychiatric Drug Side Effects Video

In 2006, the editor-in-chief of the Journal of the American Medical Association (JAMA) Dr. Catherine DeAngelis had to apologize for a pharma-tainted article that defended the use of antidepressants during pregnancy and an article linking migraines to coronary risks in women. The doctor authors, it turned out, were getting money from antidepressant and heart medication manufacturers.

But ten months later, JAMA ran a study “designed jointly by the non-Merck investigators and Merck employees” and “supported by contracts with Merck and Co” that extolled the virtues of Fosamax, a Merck bone drug. Three Merck authors on the study disclosed they potentially owned Merck “stock and/or stock options” and the article’s 11 other authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth (now Pfizer) Novartis, Procter & Gamble and Merck. Since then, the FDA has issued several warnings about Fosamax and other bone drugs.

In 2007, the AMA itself was criticized for playing both sides of the enterprise street and making $50 million a year selling the names, office addresses and practice types of its members to data miners. The AMA’s defense? Doctors could “opt out” of the privacy-invading program if they wanted to.

And then there are pharma’s “unbranded” campaigns designed to look like real public health messages or communications from grassroots groups. Who can forget PR firm Cohn and Wolfe’s faux grassroots group Freedom From Fear to sell Paxil, a pill now linked to birth defects? And the Wyeth (Pfizer) campaign, The Change You Deserve which said, whoever you are, you have depression and need Effexor?   Now, a new unbranded pharma campaign, Depression Is Real, running on radio stations, compares depression to cancer because it kills and diabetes because it doesn’t go away. Kind of like pharma’s huckstering.

http://www.opednews.com/articles/Are-You-Taking-Pills-You-D-by-Martha-Rosenberg-110721-870.html?show=votes

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Harvard Medical School Professor Among Five Psychiatrists Accused of Ghostwriting

Wednesday, July 13th, 2011

The Harvard Crimson – July 12, 2011

—Staff writer Naveen N. Srivatsa

Photo: Keri D Mabry

A complaint filed with the federal Office of Research Integrity alleged that a group of psychiatrists, including an associate professor at the Harvard Medical School, signed their names to an academic paper written by a communications firm hired by a major pharmaceutical company.

Gary Sachs, a researcher affiliated with Massachusetts General Hospital, is one of five doctors identified in the formal accusation filed July 8 by University of Pennsylvania professor Jay D. Amsterdam.

The psychiatrists allowed the medical communications company Scientific Therapeutics Information, hired by SmithKline Beecham, to draft a paper using their names, according to the complaint. The paper, according to Amsterdam, suggested that the antidepressant Paxil can help treat some cases of bipolar disorder.

SmithKline Beecham, which has since merged into the pharmaceutical company GlaxoSmithKline, manufactured Paxil.

The practice known as ghostwriting is widely condemned by scientific journals. The World Association of Medical Editors calls ghostwriting “dishonest and unacceptable.”

The complaint includes messages sent between those affiliated with the study, as well as their supervisors. The attached messages include professors saying that Scientific Therapeutics Information and SmithKline Beecham selected the first author of the paper and failed to provide the paper to all investigators before submission.

But the messages also seem to portray a feud between Amsterdam and University of Pennsylvania Associate Professor Laszlo Gyulai, one of the accused researchers. In one message, Amsterdam accuses him of stealing his research.

“As per your investigation there is little doubt that these data were misappropriated from me and used and published without my knowledge and without regard to the significant contribution that I made to this study,” Amsterdam wrote in an email to Gyulai’s supervisor.

The paper was published in June 2001, and the research was funded by grants from GlaxoSmithKline and the National Institute of Mental Health.

In an interview Wednesday morning, Sachs, an associate clinical professor of psychiatry at Massachusetts General Hospital, said that while the relationship between Amsterdam and Gyulai was antagonistic, the accusations of research misconduct should be investigated.

“There might be unhappiness between two faculty memebers, and they might escalate this. But the question is whether there is any basis to this assertion, and this is a very serious assertion,” he said. “So apart from whatever motivations there may be, they did raise assertions, and those assertions deserve to be investigated.”

Sachs said that he was involved in designing the study and that he saw the paper before it was submitted to the journal.

While he said he did not interact with anyone from Scientific Therapeutics International, he did come in contact with employees of the pharamceutical company.

“The idea that bipolar depression was important to study has been an essential part of my career. Encouraging studies in this field is obviously, as an academic, something I’d want to do,” he said. “I was very pleased that they were willing to put their drug to the test. I give them credit of actually having the trial for the drug. Interacting with them in the course of the design and execution of the study, that’d all be standard stuff to do.”

In a statement, GlaxoSmithKline said that employees were involved in the draft’s development and that the company financially supported the study. It said that the primary authors of a paper have final approval of the draft and that when its employees provide “substantive assistance” to a paper, it is disclosed.

“This article was written more than 10 years ago and we do not have details about the development of the manuscript,” a spokesperson said in the statement. “GSK is committed to complete transparency regarding clinical and case studies.”

A spokesperson for the hospital said that it is looking into the complaint.

“Massachusetts General Hospital takes allegations of research misconduct very seriously and will handle the matter in compliance with our policy to determine if there’s any validity to the complaint,” spokesperson Kristen Stanton said in an email.

Sachs said that since the filing of the complaint, he has discussed the matter with a hospital representative.

http://www.thecrimson.com/article/2011/7/12/complaint-amsterdam-sachs-glaxosmithkline/

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Australian Medical Journal Bans Pharma Advertising

Thursday, February 3rd, 2011

Pharmalot – February 3, 2011

by Ed Silverman

Concerned about the influence advertising may have on physicians, an Australian medical journal will no longer accept paid ads about prescription drugs and has called on other journals to take the same stand.

The ads could “change the prescribing practices of doctors”, wrote editors George Jelinek and Anthony Brown wrote in an editorial. “It is time to show leadership and make a stand, and medical journals have a critical role to play in this. At Emergency Medicine Australasia, we have, therefore, drawn a line in the sand and have stopped all drug advertising forthwith. We invite other journals to show their support and follow suit by declaring their hand and doing the same.”

The ban followed discussions with other emergency medicine specialists, who worried aloud that advertised drugs were supported by evidence that was neither “of reasonable quality, nor independent.” There were cases of “dubious and unethical” research practices by pharma, including ghostwriting. And academics may face pressure to withhold negative research, which could “inflate views of the efficacy” of heavily promoted drugs.

The professors also expressed concern that ads run counter to a journal’s mission to provide objective data that enables docs to make judgments based on evidence. “Meanwhile doctors – and indeed journal editors – generally deny they are influenced, yet clearly they are,” they wrote. “Drug companies value drug advertising in medical journals because it works…generating at least $2 to $5 in revenues for every dollar spent.”

Australian law only permits drugmakers to run ads in medical journals, and about a dozen specialist and subscription-based magazines and newspapers that target healthcare professionals.

Read the rest of the article here: http://www.pharmalot.com/2011/02/australian-medical-journal-bans-pharma-advertising/

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Booming Sales of Antipsychotic Drugs Often Fueled by Illegal Marketing Tactics

Wednesday, October 6th, 2010

FairWarning, October 6, 2010

By Jessica Roberts 

Antipsychotic drugs, once used to treat only the most serious mental illnesses, have emerged as the top-selling class of pharmaceuticals in the U.S., generating annual revenue of about $14.6 billion. Yet much of the sales boom has been achieved with illegal or controversial marketing tactics by major pharmaceutical companies to promote uses of the drugs that have not been approved by the U.S. Food and Drug Administration.

The result, according to an account by The New York Times, is that every major manufacturer of antipsychotic drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson  — has recently settled criminal or civil government cases for hundreds of millions of dollars or is under investigation by the Department of Justice for possible health care fraud. The criminal fines paid by Eli Lilly and Pfizer last year set records last year for the largest criminal fines ever imposed on corporations, although in the case of Pfizer, the case was built only partly on the marketing of an antipsychotic drug.

In their defense, the companies say that they follow tight business ethics guidelines and that all possible side effects of their medicines are fully disclosed. Recently, however, the government has warned that some of the drugs may be fatal for older patients and have unknown effects on children. And critics question how drugs approved by the agency for use by 1 percent of the population, to treat illnesses such as schizophrenia and bipolar mania, could have turned into top sellers, prescribed for everyone from preschoolers to octogenarians.

At least part of the answer lies in the companies’ marketing tactics. The Times reports that civil and criminal lawsuits against big pharmaceutical companies have revealed hundreds of documents showing that some company officials knew they were using questionable tactics when they marketed these powerful, expensive drugs.

According to analysts and court documents, these tactics have included payments, gifts, meals and trips for doctors, biased studies, and ghostwritten medical journal articles. These all are meant, federal investigators say, to promote the benefits and downplay the risks of the drugs, while encouraging off-label uses — that is, uses the FDA has not approved but which doctors, if they choose, can pursue with their patients anyway.

Drug companies skirt restrictions on promoting off-label uses by hiring consultants, researchers and educators to handle the job, delivering the marketing message verbally and through company-sponsored studies. “They can give a small hint, and people will take the bait,” Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, told the Times. “Psychiatric disorders are vaguely defined enough that you can stretch definitions.”

The Justice Department claims drug companies trained sales representatives to rebut valid medical concerns about unproved uses of antipsychotic drugs. For example, the department says, Eli Lilly produced a video called “The Myth of Diabetes” to sell Zyprexa, which became its all-time best-selling drug, even though evidence showed that Zyprexa could cause diabetes.

Read the rest of this article here: http://www.fairwarning.org/2010/10/booming-sales-of-antipsychotic-drugs-often-fueled-by-illegal-marketing-tactics/

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Ghostwriting 101: Pharma hires firms to write glowing reviews of a drug, then pays docs to sign off as authors

Thursday, March 4th, 2010

Scoop Independent News
By Evelyn Pringle
March 4, 2010

A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, “Glaxo Used Ghostwriting Program to Promote Paxil,” in reporting on a program called “CASPPER,” which allowed doctors to “take credit for medical journal articles mainly written by company consultants.”

“Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work,” the Associated Press said on August 19, 2009. “Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.”

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: “Paxil Product Management has budgeted for 50 articles for 2000.”

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The family was award $2.5 million.

Read entire article:  http://www.scoop.co.nz/stories/HL1003/S00045.htm

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