What’s in a reputation? Ghostly spirits stalk the medical literature

The concept sounded fishy to Dr. Adriane Fugh-Berman. She was not about to place her title on a ghostwritten article for a medical journal. However she was curious, so she performed alongside for some time.

An affiliate professor at Georgetown College Medical Middle, Fugh-Berman was contacted in 2004 by a medical communications agency working for drug maker AstraZeneca with a proposition: Would she like an writer credit score on a forthcoming article to be submitted to a journal? A couple of weeks later, Fugh-Berman mentioned, she acquired a manuscript of almost 2,500 phrases, full with an summary, footnotes and a desk. An accompanying observe requested her to return the draft with any adjustments inside every week.

The paper was concerning the dangers of warfarin, a generic anti-clotting drug, for individuals additionally taking natural dietary supplements. AstraZeneca was creating a rival drug that may supposedly be safer for complement customers. A optimistic article might give the brand new drug a promotional carry. Fugh-Berman was thought-about an professional on drug-supplement interactions, so her byline would carry some weight. However lengthy involved about overprescribing in medication, she turned out to be the incorrect particular person to ask.

Fugh-Berman declined the writer credit score, and that may have been the top of it. However just a few months later, editors of a serious journal requested Fugh-Berman to see evaluation an article they have been contemplating for publication. She shortly acknowledged it as almost the identical because the draft supplied to her, although with a distinct writer’s title.

Alerted by Fugh-Berman, editors of the Journal of Common Inner Medication rejected the article. They then printed her account of the episode, together with an editorial condemning what they referred to as “an egregious case of unethical habits” that aimed to inject ”bias and untruth into the scientific dialogue so as to improve company earnings.”

AstraZeneca and the medical writing contractor, Rx Communications, weren’t instantly fingered because the culprits. On recommendation from its attorneys, the journal recognized the drug maker as “ABC Medication” and the medical writing agency as “XYZ Communications.” As Dr. William M. Tierney, then the co-editor, not too long ago advised FairWarning: “They’d much more cash to pay attorneys than we do … I didn’t must publicly disgrace them” to make the purpose.

However Fugh-Berman was decided to out the businesses. In a bit for The Guardian she did.

Battling the fallout, AstraZeneca and Rx Communicationsdenied partaking in ghostwriting, calling the entire thing a slipshod mistake. Rx, they mentioned, had by accident despatched Fugh-Berman a manuscript developed by one other tutorial writer.

For the massive drug maker, the timing couldn’t have been worse. A short while earlier than, an AstraZeneca govt showing earlier than a British parliamentary committee asserted that the agency by no means engaged in ghostwriting.

For Fugh-Berman, now a Georgetown professor, the expertise deepened her curiosity in ghostwriting and the corruption of medical literature. In 2007, she based a undertaking referred to as PharmedOUT , which goals to coach well being care professionals about advertising and marketing practices of drug and medical machine makers.

Secure house?

In an age of distortion, propaganda and pretend information, medical literature may appear to be a protected house for trustworthy scientific inquiry, with no room for bias or spin. It isn’t so. Courtroom proceedings, investigations and whistleblower accounts have revealed an extended historical past of drug firms manipulating the literature to advertise their medication or disparage rival merchandise–with the intention of getting medical doctors to prescribe extra of their meds.

After all, they’ve extra direct methods to goose gross sales. Drug firms in 2016 spent an estimated $6 billion on direct-to-consumer adverts within the U.S., the one nation aside from New Zealand that permits them, in keeping with arecent evaluation in JAMA. That very same 12 months, the examine discovered, the {industry} spent $20.Three billion on advertising and marketing to medical doctors and different well being care professionals, together with by offering free samples, free meals and talking charges.

Much less well-known is the tactic of creating favorable medical articles to affect prescribing choices. Through the years, data and interviews present, such articles have usually concerned ghostwriting and its sketchy sidekick, ”visitor” or ”honorary” authorship. Collectively, they’ve exaggerated the position of the unbiased researchers or ”thought leaders” who’re credited as authors, whereas minimizing the position of those that did the heavy lifting–drug makers and paid medical writers.

It’s a method firms have sought to skirt a ban on selling their medication ”off-label,” or for makes use of not accepted by the Meals and Drug Administration. Docs can nonetheless write prescriptions for off-label makes use of, and favorable articles bylined by unbiased consultants make it extra seemingly they’ll.

“Ghostwritten articles can have a major affect on … doctor prescribing practices,” in keeping with a 2010 Senate workers report ready for Sen. Charles Grassley (R-Iowa). ”When distinguished physicians and scientists lend their names to an article, it raises the credibility of the findings and conclusions offered.”

In its purest (or impurest) type, ghostwriting is somebody doing all of the work however getting no credit score, whereas another person who does nothing will get all of the credit score. Typically, the state of affairs has been extra nuanced, but with drug makers figuring out the main target of articles, analyzing the info and–working with contract medical writers–creating detailed outlines or first drafts earlier than the named authors weighed in.

Two various things

On this setting, “author” and ”writer” are usually not synonyms however really imply two various things–as mirrored in a 2001 e mail from a medical communications agency to a drug {industry} shopper. “I don’t know that any resolution has been made about who’s going to write down the manuscript (to not be confused with who’s going to be the writer(s) of the manuscript … ),” the e-mail mentioned.

Courtroom data reveal instances of drug firms paying honoraria to invited authors, however there are different rewards for participating. To get authorship credit score with out breaking a sweat may also help with ”publish or perish” pressures. And analysis funding or consulting alternatives might comply with.

For his or her half, journal editors usually have had little capacity or sturdy incentive to scrutinize the provenance of articles, observers say. Drug firms are main advertisers in some journals, and as one examine discovered, articles developed with {industry} funding have been extra prone to end in profitable reprint orders.

For the reason that essence of ghostwriting is secrecy, nobody is aware of what number of ghosted articles exist, however there should be an excellent quantity. When JAMA surveyed authors of greater than 800 articles printed in 1996, it discovered that 29 p.c had ghost authors or honorary authorship, or each. One other survey printed in 2008 discovered the share had dipped, however solely to 21 p.c.

But the problem has sparked little public controversy. ”I believe {industry} affect on medical journals is just not well-known by both customers or well being care suppliers,” Fugh-Berman mentioned.

A spokeswoman for the Pharmaceutical Analysis and Producers of America, the main {industry} commerce group, advised FairWarning it had nobody who might communicate to the ghostwriting situation.

Drug maker GlaxoSmithKline declined an interview request, however mentioned in an announcement that its coverage “prohibits ‘ghost writing’ of journal manuscripts and abstracts.” In response to the assertion, Glaxo meets authorship necessities of the Worldwide Committee of Medical Journal Editors, and “exterior medical writers are both named as authors or included within the acknowledgement part of manuscripts.”

Pfizer Inc., the world’s largest drug maker, additionally refused an interview request, however mentioned in an e mail that it, too, adheres to disclosure pointers of the worldwide editors committee.

“Principally bogus”

Some within the {industry} say that critics have demonized what is definitely a collaborative course of during which tutorial consultants are engaged from the beginning, and depend on medical writers, who usually have superior levels and powerful writing abilities, for editorial help solely.

The problem is ”principally bogus,” mentioned James Beck, an lawyer and analyst on the Reed Smith legislation agency in Philadelphia, which has defended drug and machine firms in product legal responsibility instances. ”You see the resumes of many of those prime medical doctors, and so they have a whole lot of articles,” Beck advised FairWarning. “They’ll’t probably write all of them from scratch–and so they don’t.” Getting editorial help ”is a typical scientific observe,” Beck mentioned. It does “not change within the slightest what the underlying knowledge is.”

In a current weblog put up, Beck referred to as out plaintiff’s attorneys who decry ghostwriting as hypocrites, saying they ”routinely therapeutic massage (if not outright create)” the court docket filings submitted by their professional witnesses. However “let a drug/machine firm present authorship help to a busy physician or a scientist, and the identical plaintiffs’ attorneys … begin screaming and yelling that one thing horrible is going on.”

However critics say the industry-sponsored articles can lead medical doctors to prescribe medication which can be unsafe or costlier than merchandise which can be a minimum of as efficient. “There’s truthiness in a few of these articles, nevertheless it’s slanted in a approach that distorts inappropriately the message,” mentioned Dr. Jay Siwek, editor emeritus of the journal American Household Doctor. The consequence, he advised FairWarning, is “that physicians are misled, and the specified impact of writing extra prescriptions for a drug … is achieved.”

The affect is long-lasting, Siwek asserted in a 2016 letter to the editor of The BMJ (previously the British Medical Journal). “As soon as distorted data makes it into the medical literature, the harm is finished: different authors unwittingly incorporate it into different articles, spreading the distortions.”

Repentant ex-ghosters have made related factors.

Alastair Matheson, a medical author who ghosted articles from the mid-1990s till 2012, described the work as “‘spinning science to promote medication,” and mentioned he lastly stop as a result of ”I thought-about it to be unethical.” Matheson has written about ”medication’s tradition of misattribution” that goals to ”aggrandize the position of lecturers and downplay that of firms.”

What’s to not like?

Linda Logdberg, a ghostwriter for a couple of dozen years, mentioned there have been occasions when articles have been submitted for publication “with out the ‘physician-author’ seeing the ultimate draft.”

In an essay in PLoS Medication, Logdberg acknowledged that the work held highly effective sights. “The cash was good. Actually good.” she wrote. “And maybe most essential within the longer run—it was enjoyable. Touring, consuming in high-end eating places, carrying modern garments, and dashing to fulfill essential deadlines—what’s to not like?”

However Logdberg, who has a doctorate in anatomy, stop to change into a biology trainer after a falling out with a medical writing agency. The dispute concerned an article about the benefits of prescribing the Novartis drug Ritalin to deal with youngsters with consideration deficit-hyperactivity dysfunction. “I used to be unwilling to show this ugly duckling of a ‘me-too’ drug right into a marketable swan,” Logdberg wrote. Unforgivably, she additionally mentioned her ghostwriting actions with The New York Instances.

Medical author Stephen R. Braun burned his ghostwriting bridges with a 2013 essay about his spin-doctoring of articles on  testosterone alternative therapies. But for Braun, a very memorable task didn’t contain ghost writing per se.

”The Fact About Impotence” was the title of a Could 1998 broadcast of NOVA, the acclaimed public TV science sequence. The timing was hanging. Viagra, the erectile dysfunction capsule that may change into a blockbuster for Pfizer, had simply come in the marketplace. Braun was listed within the credit because the present’s co-writer, together with the remainder of the manufacturing workers. It’s unsure what number of viewers additionally noticed the inconspicuous tagline: ”This program was funded by an unrestricted instructional grant from Pfizer Inc.”

This system primarily described the impotence cures, akin to surgical procedure, that predated Pfizer’s magic capsule. However ”boy oh boy, did everybody on that undertaking know that Pfizer was funding it,” Braun advised FairWarning. “And once more, we included all the opposite remedies nevertheless it ended up being an hour-long PBS present advert for Viagra,” Braun mentioned. “Pfizer bought a fairly good piece of selling.”

Nova spokeswoman Jennifer Welsh mentioned in an e mail that the printed was produced by the New England Analysis Institutes, the recipient of the Pfizer grant. “The point out of Viagra is a factual assertion that it’s the first capsule to be accepted by the FDA,” she wrote. ”NOVA packages present factual science, they don’t advocate merchandise or positions.” Institutes officers didn’t return emails or cellphone calls.

Burning shiny

It was an informal dialog that, after almost 15 years, nonetheless burns shiny in Leemon McHenry’s reminiscence. Whereas browsing off Level Dume in Malibu and ready for a wave, a browsing buddy, Skip Murgatroyd, talked about that he needed to go away the water to attend a lecture on the College of California, Los Angeles.

McHenry knew Murgatroyd was a lawyer, however knew little about his observe. It turned out he labored for a Los Angeles agency that specialised in suing drug makers over alleged accidents from unwanted effects of pharmaceuticals. The lecture Murgatroyd was attending was about bias and distortion in medical literature, so even browsing needed to wait.

McHenry had a doctorate in philosophy and was educating at California State College, Northridge. He had coaching in logic and important considering however none within the legislation. What occurred subsequent redirected his profession, and his life. Murgatroyd invited him to evaluation paperwork from one among his instances, together with medical articles concerning the drug focused within the lawsuit. McHenry recalled that when Murgatroyd later requested his response, he responded that, primarily based on his studying of the medical literature, “you don’t have a leg to face on.”

“All of that’s ghostwritten,” Murgatroyd replied.

“This will’t be true,” was McHenry’s first thought. “This has bought to be some lawyer’s spin.”

On the time, ghostwriting proof had begun to trickle out in court docket proceedings and medical publications. As McHenry investigated, his skepticism melted away. “I believed it was unimaginable that the medical literature could possibly be corrupted like that,” he mentioned in a current interview. He had shared a typical perception concerning the purity of scientific and medical literature–that it was ”essentially the most authoritative, reliable supply of data that now we have … To have that shattered can be a monumental sort of epiphany that one has.”

McHenry went to work as a analysis guide for Murgatroyd’s legislation agency, Baum Hedlund Aristei and Goldman. The job requires sifting by means of mountains of emails, reviews and different inner paperwork obtained in authorized discovery, searching for proof that firms had exaggerated the protection and underplayed the dangers of their medication. Some inner paperwork have revealed the publication methods of drug makers and their use of ghostwriting and visitor authorship to seed the literature with favorable articles.

Extra not too long ago, McHenry’s sleuthing crossed into the sphere of toxicology, through lawsuits by victims of non-Hodgkin lymphoma, a kind of most cancers, who declare they contracted the illness from publicity to Monsanto’s Roundup weed killer. Final 12 months, McHenry printed a paper analyzing inner Monsanto paperwork concerning the improvement of defensive research that discovered Roundup was protected. He asserted that the favorable research have been produced, partly, by means of ghostwriting by Monsanto officers and contractors.

“Stylistic feedback”

Among the many paperwork was a 2015 Monsanto e mail suggesting that ”we ghost-write” parts of the research to carry down prices. The named authors ”would simply edit and signal their names so to talk,” the e-mail mentioned. In an announcement to FairWarning, Monsanto’s mother or father firm Bayer mentioned the Roundup research ”underwent intensive unbiased peer evaluation earlier than they have been printed,” and that Monsanto’s position within the research was restricted to ”formatting help, a regulatory historical past overview, and stylistic feedback on articles.”

McHenry, who’s trim and match at 63, works from the legislation agency’s 18th flooring workplace in a tony space of West Los Angeles. If there’s a gown code at Baum Hedlund, McHenry has been granted an exemption. On a day he met with a reporter, he wore denims that may as soon as have been blue, and a shirt so pale that the stripes have been barely seen.

Together with prospecting for incriminating paperwork, McHenry has authored or co-authored a string of peer reviewed papers on ghostwriting and manipulation of medical literature. He mentioned concern of being sued by drug producers has led some journals to reject his papers–forcing him to publish them in journals in Poland, The Netherlands and India. (He acknowledged that working for a legislation agency that makes a residing suing drug firms may make publishers cautious.) McHenry and his generally co-author, Australian psychiatrist and professor Jon Jureidini, are nearing publication of a ebook entitled, “The Phantasm of Proof-Based mostly Medication: Inspecting the Scientific Basis of Medical Analysis.”

Writer ”TBD”

Lately, a whole lot of inner paperwork about drug {industry} publishing methods have surfaced in product legal responsibility fits and Justice Division prosecutions of drug makers. A few of these data have been printed on-line, together with within the Drug Business Doc Archive on the College of California, San Francisco library. For instance:

—A 1999 doc ready for Pfizer by a medical writing agency outlined an formidable publications technique to advertise the antidepressant drug Zoloft. Entitled “World Vast Publications Standing Replace,” it listed greater than 80 articles printed, or within the pipeline, together with 4 during which the writer was recognized as “TBD.”

—A 2004 advertising and marketing plan for Lexapro, an anti-depressant made by Forest Laboratories, cited ghostwriting as one factor. “Bylined articles will enable us to fold Lexapro messages into articles on despair, nervousness and co-morbidity, developed by (or ghostwritten for) thought leaders,” the doc mentioned. “We’ll determine a Lexapro thought chief to put 2-Three byline articles in commerce journals, shopper publications and on the web.”

The plan additionally referred to as for coaching some 2,000 psychiatrists and first care medical doctors–together with ”nationwide and native thought leaders”–to function school for a audio system bureau program to advertise the drug.

In 2009, the Justice Division charged Forest, now a part of Allergan, with fraudulent advertising and marketing practices, citing, amongst different issues, an allegedly deceptive article drafted by a contract medical author, and kickbacks paid to medical doctors. Forest agreed to plead responsible and pay greater than $313 million to resolve prison and civil costs of lllegally selling Lexapro and two different medication.

Orders from the highest

—Wyeth Prescription drugs, now a part of Pfizer, employed the medical communications agency DesignWrite to end up favorable articles about hormone alternative merchandise used to deal with menopause signs. A 2002 e mail to workers members of Wyeth and DesignWrite ordered up extra supportive articles to counter dangerous publicity about cardiovascular dangers. ”Senior administration has charged the Publications Committee with rising the variety of optimistic … publications,” the e-mail mentioned. “They’ve requested us to publish a minimum of 1 examine per thirty days. This enhance in publication is important to problem the…destructive press”.

DesignWrite later boasted in a proposal to Wyeth that it had produced ”over 50 peer reviewed publications” about hormone alternative remedies, together with ”greater than 50 scientific abstracts and posters, journal dietary supplements, inner white papers, slide kits and symposia.”

—Merck got here beneath assault for excluding some coronary heart assault instances from a paper on a medical trial of its blockbuster ache reliever Vioxx. Lead writer Jeffrey R. Lisse, a College of Arizona rheumatologist, later defined that Merck had referred to as the photographs. “Merck designed the trial, paid for the trial, ran the trial,” Lisse advised The New York Instances. ”Merck got here to me after the examine was accomplished and mentioned, ‘We wish your assist to work on the paper.’ The preliminary paper was written at Merck, after which it was despatched to me for enhancing … Mainly, I went with the cardiovascular knowledge that was offered to me.”

Dealing with some 27,000 lawsuits blaming Vioxx for coronary heart assaults and strokes, Merck took the drug off the market in 2004. In 2007, with out admitting legal responsibility, it agreed to settle a lot of the lawsuits for $4.85 billion.

–Warner-Lambert, now a part of Pfizer, used visitor authors to advertise off-label makes use of of the anti-seizure drug Neurontin, in keeping with an evaluation of firm paperwork printed in Annals of Inner Medication. Individually, a commentary within the New England Journal of Medication said: “Though visitor authorship and industrial bias in analysis are a well-recognized risk to scientific integrity, the documentation of complete manipulation of analysis and publication associated to Neurontin is outstanding.” Warner-Lambert pleaded responsible in 2004 to costs of unlawful off-label promotion and agreed to pay $430 million in prison and civil penalties.

—Maybe essentially the most infamous case of alleged ghostwriting concerned the anti-depressant Paxil. SmithKline Beecham, now GlaxoSmithKline, had hoped for approval to market Paxil as protected and efficient for adolescent despair, however deserted the thought after medical trials have been deeply disappointing.

Information present the corporate and its medical writing contractor, a now defunct agency referred to as Scientific Therapeutics, circled the wagons. “It will be commercially unacceptable to incorporate an announcement that efficacy had not been demonstrated,” an inner doc mentioned, “as this may undermine the profile of [Paxil].”

One deliberate paper on a Paxil medical trial was shelved as a result of ”the facet impact knowledge evaluation was terribly unfavorable to our favourite antidepressant. And we hate when that occurs,” quipped a Dec. 14, 2000 emailfrom Scientific Therapeutics. “There are some knowledge that no quantity of spin will repair,” one other e mail mentioned.

At odds with the info

However quickly after, a paper about one other medical trial, referred to as Examine 329, triggered a wave of off-label prescribing of Paxil for adolescent despair. The article, printed within the Journal of the American Academy of Youngster and Adolescent Psychiatry, concluded that Paxil “is usually nicely tolerated and efficient for main despair in adolescents.” It will later be attacked as an excessive instance of spin and distortion. It ”was largely ghostwritten,” in keeping with a 2015 article in The BMJ, and ”claimed efficacy and security … that was at odds with the info.”

The manuscript was drafted by Sally Ok. Laden of Scientific Therapeutics, who had additionally penned the e-mail about ”our favourite antidepressant.” The lead writer, Dr. Martin B. Keller, thanked Laden in a letter. “You probably did an excellent job with this,” he wrote, including that he and two co-authors have been sending some ”moderately minor adjustments.” Revealed in July, 2001, the article listed 22 authors, however not Laden. A footnote said: “Editorial help was offered by Sally Ok. Laden, M.S. ”

Years later, when Laden’s deposition was taken in litigation over alleged suicide dangers from Paxil, she acknowledged drafting the manuscript, however denied ghostwriting had occurred. Sure of the named authors have been ”extraordinarily concerned” in improvement of the paper, she mentioned, and she or he had “acted at their path.” Efforts to achieve Laden have been unsuccessful.

Involved about adolescent suicide dangers, the FDA ordered a black field warning on Paxil and different anti-depressants in 2004. In 2011, the Justice Division charged Glaxo with fraudulently advertising and marketing Paxil and different medication. The federal government grievance cited the article on Examine 329, saying it ”distorted the examine outcomes and gave the misunderstanding that the examine’s findings have been primarily optimistic, once they have been, actually, primarily destructive.” The next 12 months, Glaxo agreed to pay a document $Three billion to settle prison and civil costs.

Recriminations about Examine 329 linger to the current. Responding to a damning critique  in 2015, Dr. Keller and eight of his co-authors issued a letter defending the paper and denying it was ghostwritten. ”There was completely nothing concerning the course of concerned within the drafting, revision, or completion of our paper that constitutes ‘ghostwriting,’ ” they wrote. “This examine was initiated by tutorial investigators, undertaken as an instructional / {industry} partnership, and the ensuing report was authored primarily by the tutorial investigators with {industry} collaboration.”

GSK additionally denied in a letter to one of many authors of the 2015 critique that the article was ”fraud, fraudulent or deceptive.” Noting that it had undergone peer evaluation, the corporate mentioned the paper ”precisely displays the honestly-held views of the medical investigator authors.”

It’s onerous to know

Since ghostwriting is supposed to be invisible and is revealed, if ever, years after the actual fact, it’s unknown how widespread it’s now.

“I don’t know of anybody or any examine that may actually quantify how massive of an issue ghost authorship has been,” or ”how massive of an issue it stays,” mentioned Dr. Darren Taichman, govt editor of the journal Annals of Inner Medication. “It’s very uncommon that editors are ready to really know who did what on a analysis paper.”

Taichman can be secretary of the Worldwide Committee of Medical Journal Editors, a working group drawn from 13 medical journals within the U.S. and overseas. These publications and a few others subscribe to a set of voluntary pointers on such points as disclosure of monetary sponsorship by drug firms and authors’ conflicts of curiosity.

In response to the rules, authorship credit score requires making a considerable contribution to the conception, drafting and last approval of an article. In 2013, Taichman mentioned, the committee added a requirement that authors settle for full accountability for the content material of the paper. This was achieved, Taichman mentioned, as a result of too usually when questions arose the authors would say, ” ‘I wasn’t answerable for that facet of the paper. You might want to ask another person.”

The objective is to breed belief “that authors will stand behind what they’re placing their title to,” Taichman mentioned. However regardless of the rules, he mentioned, ”if somebody needs to cover his or her contribution to the writing of a paper, it’s going to be fairly troublesome for an editor to know.”

Ghost administration

Some {industry} critics say ghostwriting has developed right into a extra ambiguous, and doubtlessly insidious, sample they name ”ghost administration.” There may be extra stress for credited authors to be considerably concerned, and {industry} sponsorship and help from medical writers are uniformly acknowledged in footnotes. However some say drug firms stay largely in command of the message by deciding on matters and producing outlines or first drafts.

“What’s modified is that firms have change into extra cautious about not solely ghostwriting an article,” Fugh-Berman mentioned. “However they’ll guarantee that their advertising and marketing messages are in it.”

Mentioned Siwek, the previous editor of American Household Doctor, “In some unspecified time in the future, I believe they [drug companies] realized that they may get the identical impact and bypass this pesky situation of trying dangerous and utilizing ghostwriters by simply making it clear.”

Paradoxically, Siwek says, higher transparency has not essentially improved the state of affairs. Fairly than instill extra warning in medical doctors, the disclosures are inclined to make them extra assured about the remainder of the data. Transparency “does nothing to decontaminate the content material; the spin remains to be there,” Siwek mentioned in a 2016 letter to The BMJ.

“The actual story in a nutshell is the contamination of the medical literature by flagrantly biased data,” Siwek mentioned, aimed toward “promoting merchandise and rising earnings moderately than bettering the well being of the American individuals.”

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