Posts Tagged ‘pharmaceutical’

Cooking the Books:The statistical games behind “off-label” prescription drug use

Monday, December 21st, 2009

Darshak Sanghavi
Slate
December 21, 2009

Years ago, mathematician John Allen Paulos described a brilliant stock scam, in which a crooked broker sends out a huge number of letters to potential clients. Half the letters say the market will rise; the other half predict the opposite. As Paulos explains, “No matter whether the index rises or falls, a follow-up letter is sent, but only to [people] who initially received a correct prediction.” On that half, the scam is repeated. After several iterations, the broker has hooked some fraction of his initial marks—the guy correctly predicted a half-dozen or so market moves!—and the unsuspecting rubes are ready to be fleeced.

Pharmaceutical companies employed a similar ruse to propel sales of drugs for “off-label” indications, or uses not green-lighted by the Food and Drug Administration. The FDA approves new prescription drugs only after clinical trials show a benefit in the form of a pre-specified outcome, such as fewer asthma attacks, better blood sugar control, or some other metric. (For example, Neurontin was approved to control seizures.) Companies are forbidden to advertise or promote the drug for any other problem. However, no law stops doctors from prescribing the drug for whatever reason they like—and they certainly do.

In 1996, a young researcher named David Franklin left Parke-Davis due to his disgust over off-label marketing of the anti-seizure drug Neurontin. (Franklin reported that one company executive told him, “[W]e need to be … holding [physicians'] hands and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything.”) A resulting class action suit was settled for $430 million in 2004, and thousands of pages of corporate documents soon ended up in a searchable digital library at the University of California-San Francisco.

Read entire article: http://www.slate.com/id/2239360/

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Australia: ADHD guidelines pulled after scandal on U.S. child psychiatrist Biederman’s tainted/pharma funded research

Tuesday, November 24th, 2009

Kate Sikora
The Daily Telegraph
November 23, 2009

CONTROVERSIAL guidelines on ADHD have been pulled by the Federal Government following claims drug company payments to a doctor have tainted the work.

The Government has been forced to stop the release of the draft guidelines and may have to rewrite them following the embarrassing scandal.

A cloud has been cast over the draft’s validity after one of the psychiatrists, whose research into anti-psychotic drugs helped form the guidelines, was accused of failing to reveal payments from drug companies.

US-based child psychiatrist Dr. Joseph Biederman is under investigation in America by authorities who have uncovered $1.6 million in payments.

The US Congress investigation has found Dr. Biederman failed to declare where all the money came from and has possibly breached federal and Harvard University research laws.

Australian authorities have been forced to admit the embarrassing discovery that has now put the guidelines – which recommend medication such as Ritalin as the best form of treatment for ADHD and are designed to help parents and doctors – in jeopardy.

Read entire article: http://www.news.com.au/story/0,27574,26386776-421,00.html

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Let Them Eat Zoloft “Pfizer exists to serve the interests of their executives and shareholders-not the public”

Tuesday, November 17th, 2009

James Ridgeway
Mother Jones
November 17, 2009

As the Senate takes up health care reform, we’re sure to be treated to yet more scenes of our elected officials bending over backwards to kiss the gold-plated butts of the pharmaceutical and insurance industries. So far, just about every new turn in the health care battle is confirming what many have known for some time: The US health care system is run largely for the benefit of these corporate giants, rather than for the American people, and no piece of legislation is likely to change that fact.

But to fully appreciate the license these industries have been given to run roughshod over the public interest, you have to take a trip to Connecticut. The state is a longtime home base for the insurance industry, with 72 companies and the nation’s highest concentration of insurance jobs. It also has more than its share of drug and biotech companies. What luck then, for these industries, that the man who appears to hold a swing vote on health care reform is their own Senator Joe Lieberman, who has enjoyed enormous financial support from the insurance companies and plenty from Big Pharma, as well.

While Connecticut may be loyal to its health care companies, the opposite clearly is not true. This week the giant drugmaker Pfizer sent shock waves across the state when it announced its decision to shut down its huge research facility in New London. While some workers will be transferred to a facility in a nearby town, the closure represents a devastating loss of industry and tax base for this working-class coastal city. It also marks the disintegration of an elaborate publically financed urban development scheme that began a decade ago.

Read entire article: http://www.motherjones.com/mojo/2009/11/let-them-eat-zoloft

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Pharma’s Drug Ads: From Million Dollar TV Ads to $1.7 Billion Internet Marketing Campaign

Monday, November 16th, 2009

On November 13th, 2009, Pharmaceutical companies flocked to a two-day FDA hearing into online drug advertising, which could influence their use of social media on the net. 1  Already, the explosive growth in online advertising has intensified public concerns: the pharmaceutical industry spent more than $1 billion on Internet ads last year and is projected to spend $1.7 billion on such marketing efforts in 2012, according to the Direct Marketing Association.2

Both Eli Lilly and Merck have received warning letters this year from the FDA accusing them of misleading online advertisements.3  But while the FDA scrambles to monitor online ads, who monitors the psychiatric-pharmaceutical industry’s use of front groups to indirectly market their products?

A Washington Post article of June 16, 2009 reported that an increasing number of pharmaceutical firms are turning to social media tools, such as Facebook, YouTube, Twitter and MySpace, to market their products.  It cites how a community site sponsored by drugmaker McNeil called “ADHD Allies”—aimed at adults with ADHD—was established and offered an online podcast on financial advice and an “ADHD self-assessment tool.”4

British psychiatrist Joanne Moncrieff explains how this ultimately increases drug sales because only a biomedical approach is promoted: “Drug companies…provide funds for pro drug patient and carer groups and address advertising or disease promotion campaigns to the general public…This influence has helped to create and reinforce a narrow biological approach to the explanation and treatment of mental disorders and has led to the exclusion of alternative” treatments.5

Such websites do not mention company’s product but rather market the “disease.” In advertising, it can be accomplished through a strategy known as “condition branding,” where “mental illness” can be pitched just like cars, beer or laundry detergent.  Witness the brand name “bipolar” and “social anxiety disorder” that drug companies marketed at a fever pitch.

John Read, PhD, Psychology Department, University of Auckland did an analysis of 54 random “advocacy” groups for Post Traumatic Stress Disorder (PTSD) through the Internet. The results, published in the Journal of Trauma & Dissociation this year, found 42% of the websites received drug company funding. The researchers found:

  • “Patients tend to trust these organizations to act in an unbiased manner” but as earlier researchers argued in some cases “patient organizations have become a mouthpiece for the pharmaceutical industry in influencing regulatory authorities.”
  •  “Drug company influence within the area of mental health is prevalent and now extends to the Internet. This influence is not always transparent. This study suggests that drug company sponsorship of websites leads to a greater emphasis on pharmacology in the treatment of PTSD,” Dr. Read’s report concludes.6

ADHD Allies/ADHD Moms

In June 2008 Concerta was given an expanded indication by FDA and is now indicated for patients aged 6 to 65.7 In July 2008, McNeill Pediatrics—a subsidiary of Ortho-McNeill Pharmaceuticals—launched what they called an “unbranded group” called “ADHD Moms.” ADHD Moms markets the trademarked name “Mom-bassadors” to get mothers into the Facebook page. 8

  • McNeill spuriously claims “the group is not product-specific, nor are there any advertisements for the company’s ADHD drug Concerta (methylphenidate).” Well not directly, but providing material for the site is a Dr. Quinn, a paid consultant and speaker for McNeil Pediatrics. 9  April White, who also provides content is a paid spokesperson for McNeil Pediatrics.10
  • On April 22 2009, McNeill launched a second ADHD-focused Facebook page called “ADHD Allies,” this time targeting adults.  The “Allies” are board members of another front group Attention Deficit Disorder Association (ADDA), funded by McNeill.11
  • The pharmaceutical company has trademarked “ADHD Allies” and “ADHD Moms.”  ADHD Allies was responsible for a “2008 Harris Interactive survey of 1,000 adults with ADHD.” Not surprisingly, the survey found the condition significantly affects them. 12

Log onto The Bipolar Journey: Living With Bipolar Depression website and while it does show AstraZeneca on the home page, there’s no mention of its blockbuster antipsychotic drug Seroquel, approved by the FDA in 2006 for “bipolar.”  The site looks like a patient information site providing facts about the “disease” and misleadingly saying that it may be caused by a chemical imbalance—for which there is no evidence.

It refers people to the National Alliance for the Mentally Ill (NAMI) that has received $23 million recently from at least 18 drug companies. The site shows that of 17 cites for the exhibit’s showing in 2009, 12 are conferences or events put on by NAMI.

It also links to The Depression and Bipolar Support Alliance, a group that received close to $1 million in pharmaceutical company funding in 2007.

According to an August 27 2009 press announcement, AstraZeneca launched its interactive exhibit, endorsed by New York psychiatrist Janet Taylor. The press release does not mention that Dr. Taylor has financial ties to the company.13

In 2005, global sales for Seroquel reached $2.8 billion.  October 20, 2006, company announced Seroquel was FDA approved for bipolar.14 Within a year, sales reached $3 billion and then soared again in 2008 to $4.66 billion.15

By funding social media front groups that talk only about the “disorder,” drug companies can overcome fears of running afoul of FDA regulations that govern drug advertising and “are embracing social networks to help brand and position their companies in a positive light with consumers and practitioners.”  The top 10 drug companies using social media are: Pfizer, Johnson and Johnson, Novartis, Boehringer Ingelheim, AstraZeneca US, Bayer, GlaxoSmithKline, Sanofi-Aventis, Roche, and Merck.16

This post was written by CCHR International.
Coming next from CCHR Int: Psycho Pharma Front Groups

1 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

3 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

5 Joanne Moncrief, in a “Study of the Influence of the Pharmaceutical Industry on Academic and Practical Psychiatry,” http://www.critpsynet.freeuk.com/pharmaceuticalindustry.htm

6 http://www.isst-d.org/jtd/mansell_&_read_ptsd_drug_cos_&_internet%20.pdf; Journal of Trauma & Dissociation, 10:9–23, 2009

12 “Adults ‘Facing’ ADHD: ADHD Allies™ Offers Unique Online Community for Adults with ADHD on New Facebook® Page,” http://multivu.prnewswire.com/mnr/concerta/36533/

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The Pharmaceutical Industrial Complex: A Deadly Fairy Tale

Wednesday, October 21st, 2009

Dr. Doug Henderson & Dr. Gary Null
Centre for Research on Globalization
October 21, 2009

It has been a particularly bad month for the pharmaceutical industrial complex in its ongoing litigations in American courts. Among the main pharmaceutical headlines, Merck’s Gardasil vaccine for HPV, now being widely administered to pre-teens, was found to be linked to amyltrophic lateral sclerosis, commonly known as Lou Gehrig’s disease; following a $1.4 billion fine in promoting one of its blockbuster drugs Zyprexa off-label, deceptive correspondence was uncovered by Eli Lilly gaming the system again by promoting another one of its drugs, Cymbalta, off-label for fibromyalgia; AstraZeneca was fined $160 million for scamming the Medicaid system in Kentucky after being fined $215 million for ripping off Alabama; Glaxo lost a Pennsylvania trial for failing to warn doctors and pregnant women of the dangers of its antidepressant drug Paxil related to birth defects; and Pfizer scored a record-breaking fine of $2.3 billion for illegally marketing several drugs over the years: Bextra, Zyvox, Geodon and Lyrica. These kinds of charges, among the many others, have become a habit for drug makers for the past dozen years.

When we speak of the pharmaceutical industry complex, it does not refer solely to private drug manufacturers. The complex, like a Matrix that holds captive the health of the nation in medical slavery by its own design and manipulation, is a consortium, a spiders’ web woven with financial attachments throughout the medical profession. In addition to the pharmaceutical and medical device firms, this complex includes every government health agency—the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the National Institutes of Health (NIH), and or course the Department of Health and Human Services (HHS)—as well as drug lobbying firms now employing a large number of former Congresspersons, insurance and HMO companies, all of the leading professional medical associations such as the American Medical Association (AMA) and the American Psychiatric Association (APA), the majority of medical schools and their research departments who are heavily funded by drug money, many of the most prestigious medical journals, and ultimately all of this filtering downward to the physicians who diagnose our illnesses and prescribe our medications and treatments.

Read entire article: http://www.globalresearch.ca/index.php?context=va&aid=15758

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Congressman Ron Paul’s Parental Consent Act

Wednesday, October 14th, 2009

Ron PaulBy John Breeding
Psychologist, Author, The Wildest Colts Make the Best Horses

On April 30, 2009, Congressman Ron Paul introduced H.R. 2218, known as The Parental Consent Act of 2009.

The bill forbids federal funding for universal or mandatory mental health screening, and also forbids money for any educational or other government agency that would use a parent’s refusal to consent to their child’s screening as basis for a charge of child neglect or abuse.

Click here for video interview with Kent Snyder, Ron Paul’s Presidential Campaign Manager, speaking about why Congressman Paul introduced the Parental Consent Act.



A little recent history is relevant. On April 29, 2002, President George Bush created the New Freedom Commission on Mental Health. In 2003, this industry-studded commission presented their recommendations for the reform of the United States mental health system.

“To aid in transforming the system,” the authors of the report wanted to do many things, including:

  • Improve and expand school mental health programs.

  • Screen for co-occurring mental and substance use disorders and link with integrated treatment strategies.

  • Screen for mental disorders in primary health care, across the lifespan, and connect to treatment and supports.

This rhetoric serves to hide the truth that New Freedom is better called No Freedom or New Intrusion, and that mental health screening really means mass marketing and target recruitment of a captive population.

By the time of these New Freedom Commission recommendations, there already existed very large numbers of citizens around the country wising up to the extraordinary intrusion of psychiatry into our schools, as demonstrated in the first four years of this millennium by a number of resolutions, education department statements and state laws, all defending a parent’s right to make treatment decisions for a child without coercion, and a child’s right to education without psychiatric labeling and drugs.

Through 2003, there had been at least 46 state bills or resolutions supporting parental choice, in 28 states, that had either passed or were still pending action across the United States.  For example, Connecticut, Minnesota and Texas had passed laws explicitly stating that a parent’s refusal to consent to the administration of a psychotropic drug to a child does not constitute neglect, therefore is not in itself grounds for Child Protective Services (CPS) investigation.  Other states have passed related laws either monitoring or curbing CPS policy in this area.

Many states are pursuing related legislation as the wave of activity in support of parental choice continues to expand.  Texas law now prohibits school personnel from suggesting a diagnosis or recommending a psychotropic drug to a parent for their child.  The public will is clearly for the schools to educate, not medicate, and for the state to allow privacy and autonomy to parents and families.  At a federal level the fight over the Child Medication Safety Act was eventually won so that nowhere in the country is it legal to require a psychiatric controlled substance as a condition of attending school.

Ron Paul has been a key leader in this effort for some time.  On October 6, 2004, he introduced an earlier incarnation of his current Parental Consent Act.  This one, aptly titled the Let Parents Raise Their Kids Act, also attempted to forbid federal funds from being used for any universal or mandatory mental-health screening of students without the express, written, voluntary, informed consent of their parents or legal guardians.

Since that time, the fight has only intensified.  In 2005 in Texas, for example, we fought tooth and nail to the bitter end to defeat a bill that would have initiated mental health screening in schools throughout Texas.  Since we have defeated them consistently, this session they tried to get a pilot program approved for San Antonio and we defeated that as well, but the psychiatric and pharmaceutical lobbies are relentless.  PsychSearch.net provides one of the best websites on mental health screening and the ongoing resistance. 

We have been aided by our awareness.  Made possible largely by the work of Pennsylvania whistleblower Allen Jones, we know that many of the New Freedom commissioners are linked directly or indirectly to the Texas Medication Algorithm Project (TMAP), which provides formulas recommending specific psychotropic drugs to treat various “mental illnesses.”  It has been revealed that TMAP pushed an off-label drug marketing scheme that appears to skirt federal law.  We know, therefore, that this commission’s recommendations are intended to encourage an expansion of the fact that “appropriate services” in today’s psychiatric world means psychotropic drugs; there are already millions upon millions of school-age children on psychiatric drugs.

Senator Charles Grassley’s work outing the severe ethical financial conflicts of so many psychiatric industry spokespersons makes it a little easier to challenge these things.  For example, it tends to impress legislators when they hear that three psychiatry department chairs—Charles Nemeroff of Emory University ($1 million from GlaxoSmithKline alone), Martin Keller of Brown University (associated with a severely compromised drug trial) and Alan Shatzberg of Stanford (who was principal investigator on a drug developed by a company in which he owned $6 million of stock) have all recently resigned their positions as a result of Grassley’s investigation.

The very high number of false positives in mental health screening is good data.  In one study at Columbia University, the authors concluded that use of the Columbia Suicide Screen would result in 84 non-suicidal teens being referred for further evaluation for every 16 youths correctly identified.  It also helps to know that these type programs tend not to work anyway.  For example, the United States Preventive Services Task Force (USPSTF) found that screening for suicide risk does not reduce suicide attempts or mortality.

Finally, the facts about the severe dangers and lack of efficacy of the various types of psychiatric drugs gets attention once the truth is made known.

I consider this to represent a tragic situation, and a clear and present danger to our children.  Here is a pledge that thousands specifically signed and that so many more are acting on in the concerted challenges around the country to this scourge:

We promise to actively resist further intrusion of psychiatry into the public schools, and will not cooperate in any way with those who act as agents of this wrong-headed government initiative.  We do not now and will not later consent to the psychiatric or psychological testing of our children by those who act as agents to implement New Freedom recommendations for universal mental health screening of our children.

The Parental Consent Act of 2009 is a great idea. Passing this bill in Washington would make a significant difference in protecting children and families against further intrusion of psychiatry into the schools. I know it would also make this Texas activist’s life a little easier!

John Breeding, Ph.D. has been a counseling psychologist in Austin, Texas for 25 years. He is the director of Texans For Safe Education, a citizens group dedicated to challenging the ever-increasing role of psychiatric drugs in schools.  He is the author of numerous articles and four books including: The Wildest Colts Make the Best Horses and True Nature and Great Misunderstandings: On How We Care For Our Children According To Our Understanding.

Click here to read The Parental Consent Act

Contact your member of Congress to support The Parental Consent Act. To find your Representative and get their contact information, go to http://www.congress.org/congressorg/directory/congdir.tt to look them up (you need to enter your zip code).

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How Pharma Can Skew Drug Trial Results: If patients taking a drug die, study may include only those that survived

Tuesday, September 29th, 2009

Tom Spears
CanWest News Service
September 29, 2009

OTTAWA – Doctors and patients may not get the full story on some prescription drugs because companies sidestep rules and hide test results, according to researchers in Canada, France and Britain.

Anyone doing a clinical trial of a drug is supposed to announce publicly that the trial is under way and describe its goals. But David Moher of the Ottawa Hospital Research Institute said many tests are conducted without this disclosure.

This allows scientists, or the drug companies who pay for the work, to release good results but quietly cancel anything that looks bad for their product.

“Selective outcome [result] reporting is prevalent,” Dr. Moher’s study concluded.

Read entire article: http://www.ottawacitizen.com/health/Drug+firms+hiding+test+results+Study/2042678/story.html

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Pfizer pays $300 million to resolve allegations of off-label marketing of its antipsychotic drug Geodon

Wednesday, September 2nd, 2009

PRNewswire
September 2, 2009

PHILADELPHIA — Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

Brian Kenney and Tavy Deming of Kenney Egan McCafferty & Young represented the Geodon whistleblowers and served as co-counsel to the Zyvox whistleblower.

As part of the record settlement, Pfizer agreed to pay $300 million to resolve allegations that it engaged in off-label marketing of its blockbuster atypical antipsychotic Geodon, which generated over $1 billion dollars in sales in 2008. The allegations were first made in a qui tam lawsuit filed by Kenney and Deming on behalf of Harrisburg psychiatrist, Dr. Stefan Kruszewski. Pfizer also agreed to pay $100 million to resolve allegations that it improperly marketed its antibiotic Zyvox. That case was filed by Ronald Rainero, a former Pfizer sales manager from New Jersey.

Read entire article: http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/09-02-2009/0005087128&EDATE

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Exposing Psychiatry’s Billing Bible “Inside the DSM The Drug Barons’ Campaign to Make Us All Crazy”

Friday, August 21st, 2009

Eugenia Tsao
Counterpunch
August 20, 2009

Some years ago, a friend told me that he had been diagnosed with a major depressive disorder and that his psychiatrist had given him a prescription for Forest Laboratories’ popular SSRI antidepressant Celexa (chemical name, citalopram hydrobromide; $1.5 billion in sales in 2003). Knowing him to be a vociferous critic of the pharmaceutical companies, I asked whether he agreed that the origins of his unhappiness were biological in nature. He replied that he unequivocally did not. “But,” he confided, “now I might be able to get my grades back up.”

This guy was, at the time, a full-time undergraduate student who managed rent, groceries and tuition only by working two part-time jobs. He awoke before dawn each morning in order to transcribe interviews for a local graduate student, then embarked upon an hour-long commute to campus, attended classes until late afternoon, and then finally headed over to a nearby café to wash dishes until nine o’clock in the evening. By the time he arrived home each night, he was too exhausted to work on the sundry assignments, essays and lab reports that populated his course syllabi. As the school year dragged on, he had become increasingly disheartened about his slipping grades and mounting fatigue and decided, finally, that something had to be done. So he’d seen the psychiatrist and was now on Celexa.

Read entire article: http://www.counterpunch.org/tsao08202009.html

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The Mothers Act Disease Mongering Campaign – Part III

Friday, July 31st, 2009

Evelyn Pringle
Natural News.com
July 31, 2009

In an article titled, “Disorders Made To Order,” in the July 2002 issue of Mother Jones Magazine, Brendan Koerner described the “modus operandi” of marketing a disease rather than selling a drug, “typical of the post-Prozac era.”

“The strategy [companies] use-it’s almost mechanized by now,” said the late Dr Loren Mosher, a San Diego psychiatrist and former official at the National Institute of Mental Health, in the article.

“Typically, a corporate-sponsored “disease awareness” campaign focuses on a mild psychiatric condition with a large pool of potential sufferers,” Koerner noted.

“Prominent doctors are enlisted to publicly affirm the malady’s ubiquity,” he said. “Public-relations firms launch campaigns to promote the new disease, using dramatic statistics from corporate-sponsored studies.”

“Companies fund studies that prove the drug’s efficacy in treating the affliction, a necessary step in obtaining FDA approval for a new use, or ‘indication,’” he wrote.

“Finally, patient groups are recruited to serve as the “public face” for the condition, supplying quotes and compelling human stories for the media; many of the groups are heavily subsidized by drugmakers, and some operate directly out of the offices of drug companies’ P.R. firms,” Koerner explained.

The disease focused on in Koerner’s article was generalized anxiety disorder, or GAD. The PR firm credited with orchestrating the successful campaign of selling the disease and Paxil to treat it, was Cohn & Wolfe, working for GlaxoSmithKline.

As an ex-employee of Cohen & Wolfe, Katherine Stone serves well as one of the “public faces” for the Mothers Act disease mongering campaign, complete with her own website, Postpartum Progress.

Read entire article: http://www.naturalnews.com/026742_depression_disease_postpartum_depression.html

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