Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!

Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Against a growing outcry over the surging price of EpiPens, a chorus of prominent voices has emerged with a smart-sounding solution: Add the EpiPen, the lifesaving allergy treatment, to a federal list of preventive medical services, a move that would eliminate the out-of-pocket costs of the product for millions of families — and mute the protests.

 

Dr. Leonard Fromer, a clinical professor of family medicine at the University of California, Los Angeles, just promoted the idea in the prestigious American Journal of Medicine. A handful of groups are preparing a formal request to the government. And Tonya Winders, who runs a patient advocacy nonprofit organization, reached out late last month to crucial lawmakers on Capitol Hill.

 

“We can save lives by ensuring access to these medications,” said Ms. Winders, chief executive of the Allergy and Asthma Network.

 

A point not mentioned by these advocates is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind EpiPens. The company would be able to continue charging high prices for the product without patients complaining about the cost.

 

An examination of the campaign by The New York Times, including a review of documents and interviews with more than a dozen people, shows that Mylan is well aware of that benefit and, in fact, has been helping orchestrate and pay for the effort.

 

The journal article says it was “drafted and revised” by a medical writing consulting firm paid by Mylan, in consultation with Dr. Fromer. And Dr. Fromer himself has served in the last year as a paid Mylan consultant — which he discloses as part of the journal article. The company has also contributed money to many other groups behind the effort, and it has met with them — and Ms. Winders’s organization in particular — to coordinate its strategy, the participants said.

 

The idea being advanced is simple: If the EpiPen makes the federal preventive list, most Americans would have no insurance co-pay when getting the product. That means they could obtain the medication with no direct cost, regardless of its retail price. Mylan could keep the EpiPen at the current price, or perhaps raise it more, while keeping patient anger at a minimum.

 

Instead, the federal government, health insurers and employers would pay the bill. Those costs, in turn, could be passed on to consumers in other ways, as in higher premiums or higher co-pays on other drugs.

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Two Case Studies of Pharma Marketing Influence Over Science & Journal Publications

Two Case Studies of Pharma Marketing Influence Over Science & Journal Publications | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Inappropriate prescription and overconsumption of pharmaceuticals is one of the most pressing public health concerns in North America. Aggressive pharmaceutical promotion practices are widely recognized as a major contributing factor. Two recent medical journal articles provide further evidence of serious problems with the scientific record that has become an intrinsic part of pharmaceutical marketing.

 

Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry’s paper in the International Journal of Risk and Safety in Medicine is a case study of how the pharmaceutical company Foster used a scientific publication to boost prescription of its blockbuster anti-depressant citalopram. A paper by Joanna Le Noury and colleagues in the British Medical Journal is the first publication produced as part of an innovative initiative by the scientific community aimed at correcting the scientific record on a host of pharmaceutical products. The study involves a reanalysis of the raw data of a Smithkline Beecham (now GSK)-sponsored published study on the efficacy of paroxetine and imipramine for the treatment of depression in adolescents.

 

That both publications deal with anti-depressants is not entirely surprising. They have been among the most prescribed—in fact overprescribed—drugs of the last decades. The vagueness of diagnostic criteria and the subjective nature of efficacy measurements in relation to most mental health conditions further facilitate data manipulation. Yet it should not lull us into thinking that the problems are restricted to psychiatric drugs. Both papers confirm … that industry control over the design, conduct, analysis, and reporting of clinical drug trials has turned many scientific publications into marketing tools. It has enabled the industry to selectively report positive results, hide negative results, manipulate statistical tools for favorable outcomes, and underplay problems.

 

Both papers reveal problems of scientific integrity in pharmaceutical industry-sponsored publications and raise serious questions about the collaboration of academic scientists. In light of what is being exposed in these and in many other related publications, it is remarkable how academic institutions remain silent about the alleged scientific misconduct by some of their researchers.

Pharma Guy's insight:

Also read “Researchers Demand APA Retract ‘Deviant’ Celexa Article That Promotes Rx for Kids”; http://sco.lt/8yaLKL

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Saxenda for Weight Loss: A #pharma Ghost Writing Case Study

Saxenda for Weight Loss: A #pharma Ghost Writing Case Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Weight-loss medications have had a checkered history. But after a long drought in the diet drug market, several new ones have recently been introduced. Last April, drugmaker Novo Nordisk announced its entry, a daily injection called Saxenda, which contains a higher dose of the active ingredient in the company's diabetes drug Victoza.


It's too soon to say what the $1,000-per-month Saxenda will mean for long-term weight control.


But it provides a window into how the pharmaceutical industry is influencing the portrayal of its products in academic journals, a development that has some experts worried.


The same week Saxenda was announced, a top obesity research journal posted a preview of an article that made a strong case for weight-loss pharmaceuticals, specifically touting liraglutide, the scientific name for Saxenda.


At the end of the nine-page article, author Frank L. Greenway, a physician and researcher, disclosed that the drugmaker had paid a consultant to provide him with "writing assistance" on the manuscript. What's more, he wrote that the company, which has U.S. operations in Plainsboro, N.J., got to review the article before publication. In an interview, Greenway said he wrote the article at Novo Nordisk's suggestion.


Greenway, the review author, said Novo Nordisk proposed the idea for the article, to reinforce the idea that obesity is a medical condition.

"They said, 'Can you help write a review to support what is in the literature, to show there are reasons why this should be thought of as a chronic disease rather than bad habits?' " he said.


The writing assistance was provided by a consulting firm called AXON Communications, which has offices in London, Toronto, and New York, but Greenway said he held final responsibility for the content.


"It was sort of a cooperative effort," Greenway said. "I came up with things, and they came up with things."

Pharma Guy's insight:

Meanwhile, Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, sent FDA’s OPDP Director Tom Abrams a letter on March 31, 2015, urging him “to stop the apparently violative off-labelpromotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs, including Victoza. Now we know why weight loss was mentioned in the ads. Read more about this here: http://bit.ly/1PaM0Ke 


Take my ghost writing survey: https://www.surveymonkey.com/r/2V5GR5X 

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Defining "Ghostwriting": Drug Industry vs. Academia

Defining "Ghostwriting": Drug Industry vs. Academia | Pharmaguy's Insights Into Drug Industry News | Scoop.it

BMJ Author Alastair Matheson describes how the pharmaceutical publications industry seeks to legitimise ghostwriting by changing its definition while deflecting attention from wider marketing practices in academic publishing

 

During the past decade, the pharmaceutical publications trade has campaigned to persuade medicine, journals, ethicists, and the media that it is opposed to ghostwriting. Yet industry practices have changed little, and commercial drafting of clinical trial reports, consensus statements, and reviews that are authored by recruited academics remains routine. Here, I show that industry’s opposition is based on a redefinition of the term ghostwriting that obscures the continued, widespread use of the practice as originally defined in medical journal literature. I also argue that the ghostwriting debate has deflected attention from the broader set of strategies through which marketing influences medical publications. The use of writers, regardless of whether they are called ghosts, is just one of several options for building commercial perspectives into academic literature, then spinning their attribution to strengthen credibility.

 

As the figure shows, this attempt to redefine ghostwriting is based on two arguments. Firstly, it is claimed that a critical characteristic of ghostwriting is secrecy, and if industry writers are disclosed it should not be considered ghostwriting. The second argument is that the appropriate level of credit is what matters in medical journal articles, and because writers merit only a footnote rather than authorship, they should not be called ghosts when they receive one. In support of this contention, it is argued that composition is technical, not intellectual; that writers are not experts in the subject matter; and, by industry, that academic authors “direct” content and have the final say over the manuscripts that medical writers compose.

Pharma Guy's insight:

Fellow pharma blogger Rich Meyer has said: "Medical journal articles sponsored by drug companies are part of marketing," says Meyer. "That is a fact of a capitalist business that has to market to medical professionals. 'Ghostwriting' has been around for over 20 years and is standard industry practice for the drug industries. I personally see nothing wrong with ghostwriting as long as it is made clear at the beginning of the article who wrote it and who endorses the content." What do you think? Take my ghost writing survey: https://www.surveymonkey.com/r/2V5GR5X

 

Also read: “Saxenda for Weight Loss: A #pharma Ghost Writing Case Study”; http://sco.lt/4y5Ygb

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Researchers Demand APA Retract "Deviant" Celexa Article That Promotes Rx for Kids

Researchers Demand APA Retract "Deviant" Celexa Article That Promotes Rx for Kids | Pharmaguy's Insights Into Drug Industry News | Scoop.it

More than a decade ago, a published study touted the benefits of using the Celexa antidepressant to treat children and teens. A recent analysis, however, alleged the study had numerous problems — notably, there was no difference between the drug and a placebo. And so, the researchers and several other academics want the medical society and the journal that published the study to issue a retraction.

In a letter sent Tuesday to the American Psychiatric Association, the researchers maintain the original 2004 study, which was published in the American Journal of Psychiatry, contained “gross misrepresentations” about the safety and effectiveness of the drug. They also allege the study reflected the “pervasive influence” of the marketing objectives of Forest Laboratories, the Celexa manufacturer, since the drug was never approved for use in youngsters.

The researchers wrote that procedural deviations in the study were not reported; negative outcomes were not reported; side effects were misleadingly analyzed; and drafts of the study were prepared by company employees and outside ghostwriters. These points were highlighted in their analysis of the 2004 study, which was published last May in the International Journal of Risk & Safety in Medicine.

“We believe that the unretracted … article represents a stain on the high standard of the American Journal of Psychiatry and the American Psychiatric Association,” they wrote to APA president Dr. Maria Oquendo. “Neither the AJP nor the APA can claim to be a leader in scientific research and moral integrity, while failing to redress this article that negligently misrepresents scientific findings.”

[Most antidepressants don’t work on kids and teens,  one study found.]


An APA spokeswoman did not respond when asked whether the organization will consider issuing a retraction.

The researchers maintain a retraction is warranted because the study “continues to be cited uncritically in the psychiatric literature” as evidence that Celexa is effective in treating adolescent depression. “Our main concern is that children and adolescents are continuing to be at risk of harm unnecessarily because well-intentioned physicians have been misled,” they wrote the APA.

The demand for a retraction follows years of controversy over the extent to which some drug makers manipulated clinical studies in order to broaden the market for their medicines.

Pharma Guy's insight:

Fellow pharma blogger Rich Meyer has said: "Medical journal articles sponsored by drug companies are part of marketing," says Meyer. "That is a fact of a capitalist business that has to market to medical professionals. 'Ghostwriting' has been around for over 20 years and is standard industry practice for the drug industries. I personally see nothing wrong with ghostwriting as long as it is made clear at the beginning of the article who wrote it and who endorses the content." What do you think? Take my ghost writing survey: https://www.surveymonkey.com/r/2V5GR5X

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