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Disease mongering and drug marketing

Shidonna Raven Garden and Cook

Howard Wolinsky
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Source: US National Library of Medicine – National Institutes of Health
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Summary

Does the pharmaceutical industry manufacture diseases as well as drugs?

Most people may not have heard of metabolic syndrome, but that is likely to change. Once known mysteriously as Syndrome X, the condition, a precursor to heart disease and type 2 diabetes, is about to be transformed into a household name by the US pharmaceutical industry and its partners in the medical profession. A society dedicated to addressing the condition has been organized, a journal has been started, and an education campaign launched. Patients are already being tested for metabolic syndrome. As the trade publication Pharmaceutical Executive said in its January 2004 issue: “A new disease is being born” (Breitstein, 2004).

…industry has found itself under fire from detractors who contend that, in the pursuit of profits, companies are in league with medical doctors and patient advocacy groups to ‘disease monger’…

The situation is reminiscent of the attitude towards cholesterol. Twenty years ago, physicians were not concerned about the effects it might have on heart disease. Today, thanks to efforts by pharmaceutical companies, high cholesterol levels are now recognized as a major health problem. In fact, IMS Health, a global healthcare information company, reports that the two best-selling drugs in 2004 were statins: Lipitor® (atorvastatin calcium) from Pfizer (New York, NY, USA)—valued at US$10.6 billion with growth of 13.9% over the previous year—and Zocor® (simvastatin) from Merck (Whitehouse Station, NJ, USA). Pharmaceutical Executive noted: “The emergence of cholesterol reduction as a market was a major event for pharma. Metabolic syndrome promises to be as big or bigger” (Breitstein, 2004).

However, critics note that not every new disease for which the pharmaceutical business provides a drug is necessarily a major public health problem, but rather a venue for drug companies to increase revenues. Pharmaceutical companies research, develop and exploit drugs to prevent, control and cure diseases and treat symptoms. Companies then market these medications to recoup their investments and reward shareholders. It would seem to serve the interests of society, but some critics characterize it as a vicious circle in which businesses invent new diseases to match their existing drugs. Increasingly, industry has found itself under fire from detractors who contend that, in the pursuit of profits, companies are in league with medical doctors and patient advocacy groups to ‘disease monger’: convince people that their usually mild ailment urgently needs drug treatment.

The late medical journalist Lynn Payer addressed the issue in the early 1990s in her book Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick. She wrote: “Disease-mongering—trying to convince essentially well people that they are sick, or slightly sick people that they are very ill—is big business…. Disease mongering is the most insidious of the various forms that medical advertising, so-called medical education, and information and medical diagnosis can take.” Similarly, Arthur Caplan, Professor of Bioethics at the University of Pennsylvania, Philadelphia, USA, last December told the popular American TV programme 60 Minutes, “If you want to stir up worry in the public, and you’ve got the advertising dollars to do it, you can turn almost anything into a disease.” The focus of the 60 Minutes report was the recent emergence of a market for adult attention deficit disorder (ADD)—the traditional view was that ADD afflicted only children who would eventually outgrow it.

Critics such as Payer and Caplan maintain that the routine human condition…is increasingly being re-defined as disease…

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Critics such as Payer and Caplan maintain that the routine human condition—unhappiness, bone thinning, stomach aches and boredom—is increasingly being re-defined as disease: depression in its milder forms, osteoporosis, irritable bowel syndrome and attention deficit disorder. Likewise, risks factors, such as high cholesterol and high blood pressure, are declared diseases in their own right—hyper-cholesterolaemia and hypertension—with falling thresholds resulting in more people considered to be sick. In other cases, drugs approved for devastating illness, such as clinical depression, are indicated for milder conditions, such as shyness, which is now dubbed ‘social phobia’.

One such example is Strattera® (atomoxetine hydrochloride), developed by Eli Lilly & Co. (Indianapolis, IN, USA) and approved in November 2002 by the US Food and Drug Administration (FDA) for treating ADD in children, teens and, for the first time, adults. One Lilly advertisement shows a series of photographs of an uptight-looking model, and asks in the headline: “Distracted? Disorganized? Frustrated? Modern Life or Adult ADD?” The advertisement notes that adult ADD can go undiagnosed because “its symptoms are often mistaken for a stressful life.” The commercial suggests that readers get checked out by their physician, because Strattera®, the first approved medication for adult ADD, can help “you stay focused, so you can get things done at work and at home.”

“I certainly have watched adult attention deficit disorder start to spread out from the first grade/kindergarten crowd right up to adulthood. I am suspicious because I think that this expansion is fuelled by Lilly and Strattera®,” Caplan commented. “I don’t like the way their website [suggests that] people go pester their doctor if they have problems waiting in lines or get frustrated being put on hold on the phone.” Lilly did not respond to a request for comment.

Adult ADD has been a favourite target of the critics. But psychiatrist Peter Jensen, a mental health researcher at Columbia University (New York City, NY, USA), concedes there is a dearth of epidemiological research on adult ADD, which can be a real condition that impairs and disables people. “Pharmaceutical companies are businesses that are out there to make money and sell things. But saying that diseases are invented seems a little over the top. [Companies] certainly spread information and increase awareness, but you can’t sell it to the FDA that way,” said Jensen, who serves on the governing board of Children and Adults with Attention–Deficit/Hyperactivity Disorder (CHADD; Landover, MD, USA), a non-profit patient support group. “Illness is defined in a social context. Value systems are inherent in medicine. With adult attention deficit disorder, some people whose brains are easily distracted are [annoyed] at being labelled [and] will say that they are just high energy and creative; others will be thankful they were diagnosed, treated and had their attention span restored to almost normal.”

…it is not only companies who are to blame, but also physicians who diagnose a disorder and prescribe a drug, as well as patients who feel that they have a serious disease that needs treatment

Not surprisingly, the pharmaceutical industry does not buy the ‘disease mongering’ critique. “Our [industry’s] job is to look for cures, not to create disease. It’s up to the medical community to develop new diagnostic tools and ways to evaluate patient response,” said Alan Goldhammer, Associate Vice President for Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group based in Washington, DC, USA. He maintains that drug regulators, such as the FDA, approve drug therapies on the basis of clinical trials. “One can argue you can’t do a clinical trial because if it’s not a disease, it’s unethical to treat people with a drug if you’re not going to come up with any potential benefits. There are a number of checks and balances throughout the development process that are totally external to the pharmaceutical companies.”

Critics maintain that it is not only the pharmaceutical industry that has a role in the creation of new diseases, although they certainly fuel the process. For this reason, Australian journalist Ray Moynihan, a visiting editor at the British Medical Journal and co-author of the forthcoming book Selling Disease: How Drug Companies are Turning Us All into Patients, describes the process as ‘corporate-sponsored drug creation’ because it also involves physicians and patient groups. “There are informal alliances of doctors, drug companies and increasingly patient groups that help to widen the boundaries of illness in order to widen markets for those selling treatments. Often this process is driven by the medical profession, but it’s driven with fuel provided by the drug companies,” he said. Nevertheless, drug companies have an important role in the process. “The meetings where these disorders are defined and expanded are all drug-company funded,” Moynihan said. “Drug company activity lubricates this process, but it’s often not corporate executives in the driving seat. Often it’s the so-called thought leaders at the top of the tree in their profession and in their specialties.”

Furthermore, it is not always obvious where the border should be defined between a mild symptom and a disorder that needs medical attention. “I wouldn’t draw such a clean line between manufactured and real diseases,” said Joe Dumit, Associate Professor of the Anthropology and Science-technology Studies’ Programme at the Massachusetts Institute of Technology (Cambridge, MA, USA). He has been studying the topic of disease creation as part of his work on how patients with controversial sociomedical conditions, such as chronic fatigue syndrome, Gulf War syndrome and multiple chemical sensitivity, organized themselves to obtain research funding from the US National Institutes of Health. Dumit found that when patient groups were backed by pharmaceutical companies, such as patients with ADD and post-traumatic stress disorder (PTSD), the character of the debate changed entirely. “When Zoloft [®; sertraline hydrochloride] was approved [in 1999 for PTSD], almost every article that came out about PTSD now more or less no longer questioned the existence of the disease, but instead talked about the treatment and whether [PTSD is] underdiagnosed or overmedicated,” he said. In addition to forming alliances with patient groups, drug companies also attempt to “maximize the detectable prevalence of conditions as part of the economic rationale for growing the market for the medications,” said Dumit. “Once you decide on a threshold like a cholesterol level or an amount of irritation in your bowels, and once you decide there’s a drug that could reduce that in a population, they have a strong incentive to market to that whole population.”

One such example is social anxiety disorder, better known as shyness. GlaxoSmithKline (Uxbridge, UK) had the indications for its antidepressant Paxil® (paroxetine hydrochloride) extended to treat social anxiety disorder, an extreme form of shyness marked by fear of public speaking, eating in front of others or using public bathrooms. The FDA approved this new indication in October 2003. However, “shyness is a new disease invented by Glaxo,” said Sidney Wolfe, executive director of the Public Citizen’s Health Research Group (Washington, DC, USA). “In a pathological way I’m sure that people are so shy it can be a disease. It can be a real downside for people. A lot of these people are depressed. A number of these people are shy because they have been physically or sexually abused when they were younger. Shyness is generally a symptom of something else and to gloss over finding the cause and to just throw a drug at someone is doing a disservice.” GlaxoSmithKline did not respond to a request for an interview.

In the end, it is not only companies who are to blame, but also physicians who diagnose a disorder and prescribe a drug, as well as patients who feel that they have a serious disease that needs treatment. “What you have in social anxiety disorder is senior clinicians who are often connected with [several] different drug companies promoting this almost as a horrifying psychiatric disease,” Moynihan explained. He therefore lays some blame on the medical profession if they are not forthcoming about these connections. “I just don’t think you can be credible when you’re taking money from drug companies. And often when these [experts] are communicating with the public, the public does not know of those ties,” Moynihan said. “This is the marketing of fear. This is not a healthy way to run a society. It’s putting disease at the centre of human life.”

The USA is the epicentre for both drug and drug-marketing innovation. In addition, it is the only developed country apart from New Zealand that allows direct-to-consumer advertising for medications. According to Moynihan, consumers are exposed to an average of ten drug advertisements per day on news programmes, sitcoms and soap operas, which has a major impact on their view of disease. “The drug ads are changing perceptions of human ailments and conditions and experiences,” he said. Referring to the process in which disease prevalence is maximized, Moynihan cited GlaxoSmithKline’s campaign to market Paxil in the late 1990s, when pamphlets were distributed suggesting that one in eight Americans had social anxiety disorder. “One in eight Americans! This is clearly an absurd fiction. The point of that is to try and make ordinary people feel sick,” Moynihan said.

It’s not healthy for children or adults to sit in front of a wall of drug-company promotion every day that tells healthy people they’re sick.

Although other developed countries may not have direct-to-consumer advertising, they are not immune to the influence of marketing campaigns. “This is a global phenomenon,” Moynihan said. “In other countries, you can’t advertise drugs direct to the public, but you can run and sponsor disease awareness campaigns and that’s what they see in Europe and Australia.” In fact, in the autumn of 2003, Germany’s largest weekly news magazine Der Spiegel devoted a cover story on the topic, based on German science journalist Jörg Blech’s book Die Krankheitserfinder (The inventors of disease), which analyses how the pharmaceutical industry invents new diseases to increase sales of their drugs.

Jerry Avorn, a medical professor at Harvard University and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital (Boston, MA, USA), is a long-time critic of the drug industry’s marketing practices. However, he is also sceptical of the social critics: “The reason we’re not still using leeches is we base our decisions about drugs on well done clinical trials of what works and what doesn’t. Nothing that comes out of the realms of anthropology or philosophy matters much if the science isn’t taken into account.” According to Avorn, there are two extremes in the discussion: those who overpromote the pill-for-every-ill philosophy and nihilists who view diseases as being invented. “The truth is somewhere in the middle,” he said.

Faced with increasing costs for healthcare services to cover drug prescriptions, politicians have also begun to investigate the issue of disease mongering. In 2004 and 2005, the British House of Commons held hearings on practices of the pharmaceutical industry, including disease mongering. In March 2005, the House of Commons Health Committee published a report, The Influence of the Pharmaceutical Industry, in which it expressed concerns about the effects of “medicalisation of our society—the pill for every problem.” The committee did not blame this trend solely on the pharmaceutical industry, but rather said the industry has encouraged it by acting as a “’disease monger’, with the aim of categorising an increasing number of individuals as ‘abnormal’ and thereby requiring (drug) treatment. This process has lead to an unhealthy over-reliance on, and an overuse of, medicines. It also diverts resources and priorities from more significant disease and health problems” (House of Commons, 2005).

To increase people’s awareness of disease mongering, Moynihan called for “a more robust conversation” on regulation. “The disease-awareness campaigns need to be seriously regulated. It’s not healthy for children or adults to sit in front of a wall of drug-company promotion every day that tells healthy people they’re sick,” he said. “I actually think quite strongly that there must be a conversation about how or if to regulate this. I think that’s extremely unlikely [in the USA] in the near future. I think the Europeans are a little more civilized about this stuff. And in fact the Europeans recently rejected loosening the rules on advertising.” As governments and public healthcare systems are increasingly confronted with the high cost of medications, no doubt the issue of medicalization and disease mongering will become even more important in future debates.Go to:

References

  • Breitstein J (2004) The making of a new disease. Pharma Exec 1 Jan, www.pharmexec.com [Google Scholar]
  • House of Commons (2005) The Influence of the Pharmaceutical Industry. Fourth Report of Session 2004–2005, HC 42-I. London, UK: The Stationery Office Limited [Google Scholar]

This interesting article from the health care industry discusses the huge push of the pharmaceutical industry to create disease and prescribe drugs motivated by profit. What medicines / drugs do you take? Why? How did you obtain the disease to require the medication?

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Opioids Crisis & Kids

Protecting Teens from Rx Opioids: Ask, Manage, Talk

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Source: Mass Gov
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What medications do your children take? Why? How do you protect them from addiction?

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Obama talks about the Opioid Crisis

Obama turns attention to growing opioid abuse problem

Shidonna Raven Garden and Cook

Source: PBS
Shidonna Raven Garden and Cook

Do you know someone with an addiction? Do you know someone who has an opioid addiction? Did the addiction begin with a prescription?

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Consulting giant McKinsey allegedly fed the opioid crisis. Now an affiliate may profit from treating addicts.

Source: NBC News
Photos Source: NBC News

McKinsey’s wholly owned hedge fund affiliate, MIO Partners, holds indirect stakes in addiction treatment centers and a maker of overdose treatments.

Image: An arrangement of prescription Oxycodone pills in New York.
Source: NBC News
Shidonna Raven Garden and Cook

An arrangement of prescription Oxycodone pills in New York.Mark Lennihan / APFeb. 8, 2021, 5:02 AM ESTBy Gretchen Morgenson

McKinsey & Co., the global consulting giant, agreed to pay nearly $600 million last week to settle allegations by 49 states that its work for large opioid manufacturers helped “turbocharge” sales of the drugs, contributing to an addiction epidemic that rocked the country and has caused more than 400,000 deaths.

The settlement is a black eye for the firm, which holds itself out as the preeminent global consultant advising corporations and governments. But because most of the money to be paid by McKinsey will go to state programs funding addiction treatment centers and recovery services, the deal may allow a McKinsey hedge fund affiliate to generate investment gains, an NBC News investigation has found. That’s because the firm’s wholly owned hedge fund affiliate, called MIO Partners, holds indirect stakes in addiction treatment centers and a maker of overdose treatment products.

In addition, investment records show, during the years McKinsey was helping opioid makers propel sales of the drugs, MIO Partners held stakes in companies that profited from increased usage.

The MIO investment records don’t provide enough detail to determine how much it has made or stands to make from opioid-related investments. But they show that MIO, which is run on behalf of current and former McKinsey employees, invested in companies that benefited during the rise of the opioid crisis and now holds stakes in companies that could profit from remediation efforts in the aftermath.

A McKinsey spokesman said it is “false and absurd” to suggest that the firm will benefit financially from the big state settlement. “McKinsey has no visibility into or control of how settlement money will be used by the states,” he said. In addition, he said, the hedge fund and the firm’s consulting business are “operationally separate,” and the firm’s past stakes in opioid makers through MIO were taken by outside investment managers whose decisions McKinsey doesn’t direct or control.

Source: NBC News
Shidonna Raven Garden and Cook

DEC. 10, 201901:39

But Marianne Jennings, a professor of legal and ethical studies in business at the W.P. Carey School of Business at Arizona State University, said the simultaneous operation of the hedge fund and McKinsey’s vast consulting business poses potential conflicts that aren’t easily remedied.

“On conflicts of interest, there are two ways to handle them — you disclose them and manage it or you don’t do it,” Jennings said. “I don’t know how you manage that unless you can show me there is absolute isolation of this fund. No matter how you slice it, you benefit. I don’t see how you don’t have an interest in that and input in that.”

MIO Partners oversees its investments with a staff and a 14-person board, regulatory filings show. Eight current or former McKinsey executives are directors, joined by six non-McKinsey directors, four of whom joined recently.

MIO’s management selects an array of investment managers to deploy its $14.6 billion. They make investment choices independent of MIO and are compensated by McKinsey, according to an independent study commissioned by the Financial Oversight and Management Board for Puerto Rico, a federal watchdog that monitors the island’s budget. After MIO selects its investment managers, it may discuss individual investments with them, the study said.

McKinsey says the MIO structure is “not unusual.” But it is. Most large companies, including all the major consulting firms, hire third-party firms like Fidelity and Vanguard to oversee their employees’ retirement accounts. Those firms typically offer employees a handful of big-name mutual funds to choose from, letting them make their own investment decisions. The holdings of such mutual funds are transparent, while MIO’s stakes are more opaque.

Source: NBC News
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DEC. 10, 202004:32

Since 2010, Labor Department filings show, a retirement fund managed by MIO has amassed a $108 million stake in Deerfield Management Co., a $10 billion health care investment firm based in New York. Two top Deerfield executives previously worked at McKinsey.

During the years McKinsey’s hedge fund has invested with Deerfield, the firm has taken large stakes in opioid manufacturers, in distributors of the drugs and in addiction treatment facilities. In 2018, Deerfield’s many holdings throughout the sector led an anti-opioids group to label its strategy “a vertical integration of human misery.”

In 2017, for example, Deerfield was a 6 percent shareholder in Mallinckrodt, a major opioid maker that filed for bankruptcy protection last year after it faced enormous legal liabilities for the role critics accused it of playing in the crisis. From 2011 through 2016, Deerfield held a stake — at one point valued at $90 million — in Teva Pharmaceuticals, an opioid maker and defendant in national opioid litigation that it settled with plaintiffs, denying the allegations, in 2019. Deerfield also took stakes in two distribution companies ensnared in government-led opioid litigation: McKesson and Cardinal Health. Both companies have denied wrongdoing.

Deerfield didn’t respond to an email seeking comment about its investments in the opioid industry; the phone number listed on its website has been “deactivated.”

Source: NBC News
Shidonna Raven Garden and Cook

October: OxyContin maker Purdue Pharma to plead guilty as part of $8 billion settlement

OCT. 21, 202001:30

In 2017, Deerfield Management agreed to pay $4.7 million to settle charges by the Securities and Exchange Commission that it had profited in trades while failing to prevent its employees from misusing material, nonpublic information. The agency alleged that Deerfield had received nonpublic information about coming policy changes at the Centers for Medicare & Medicaid Services and generated over $700,000 in profits. Deerfield neither admitted nor denied the allegations.

Adamis Pharmaceuticals, a company that develops products to treat opioid overdoses, may also benefit from opioid settlement funds. According to an SEC filing from last summer, MIO owned 26 percent of the company’s preferred shares; the stake was purchased through an outside investment manager.

The McKinsey spokesman reiterated that its third-party managers make their choices independently of MIO.‘Counter the emotional messages’

Investigators in Massachusetts last year released internal emails and other documents detailing McKinsey’s role in helping push the sale of opioids as a consultant for Purdue Pharmaceuticals, the maker of OxyContin. McKinsey worked with Purdue for 15 years, starting in 2004, the states said. Last year, Purdue pleaded guilty to three felonies as a result of conduct spanning a decade — 2007 to 2017 — while it was working side by side with McKinsey. Purdue agreed to pay $8.3 billion.

Investigators said McKinsey designed Purdue’s marketing schemes, including a plan to “turbocharge” OxyContin sales at the height of the opioid epidemic. McKinsey also advised Purdue to maximize its OxyContin profits by focusing on higher, more lucrative doses and scheduling more visits by Purdue sales representatives to high-volume opioid prescribers. McKinsey encouraged Purdue to get opioid manufacturers to band together to “defend against strict treatment” by the Food and Drug Administration and worked with the company on ways to “counter the emotional messages from mothers with teenagers that overdosed in OxyContin,” Massachusetts filings show.

Massachusetts Attorney General Maura Healey said of the settlement, “Our communities will receive substantial resources for treatment, prevention, and recovery services, and families who have seen their loved ones hurt and killed by the opioid epidemic will have the truth exposed about McKinsey’s illegal and dangerous partnership with Purdue Pharma.”

Image: Maura Healey
Massachusetts Attorney General Maura Healey speaks to reporters at the State House in Boston on Jan. 25, 2016.Steven Senne / AP file
Source: NBC News
Shidonna Raven Garden and Cook

McKinsey said it believes its past opioid work was “lawful.” It said it agreed to the settlement “without finding or admission of wrongdoing or liability of any kind.”

Money from the settlement will create the Massachusetts Opioid Recovery and Remediation Fund “to expand access to opioid use disorder prevention, intervention, treatment, and recovery options,” according to the state.

Recovery Centers of America, an addiction treatment company in which Deerfield Management invested $331 million in 2015 and 2016, operates addiction treatment facilities in Massachusetts, New Jersey, Pennsylvania and other states that were part of the McKinsey settlement.

Purdue Pharma offers $10-12 billion to settle opioid claims

Kevin Sneader, McKinsey’s global managing partner, said that in striking the settlement, “we chose to resolve this matter in order to provide fast, meaningful support to communities across the United States.”

“We deeply regret that we did not adequately acknowledge the tragic consequences of the epidemic unfolding in our communities,” he said. “With this agreement, we hope to be part of the solution to the opioid crisis in the U.S.”

McKinsey’s hedge fund has come under scrutiny before. In 2018, The Wall Street Journal reported that the hedge fund held investment stakes in companies it had advised in bankruptcy proceedings. The proceedings require advisers to be unconflicted in their work, and rules bar them from having stakes in cases’ outcomes. In 2019, McKinsey paid $15 million to settle an inquiry by a unit of the Justice Department into whether it violated disclosure rules designed to prevent conflicts of interest in corporate bankruptcies.

And the 2019 study commissioned by Puerto Rico financial oversight board noted that MIO investments in that bankruptcy case “could be perceived as a conflict.”Gretchen Morgenson

Gretchen Morgenson is the senior financial reporter for the NBC News Investigative Unit.

Pharmaceutical companies pump medicine commercials on TV, push medicines / drugs that have not undergone proper clinical trails to the medical professionals treating you giving them incentives such as speaking trips in Hawaii creating a drug epidemic such as the current opioid crisis and then invest in the treatment centers designed to “cure” you from medical professional and pharmaceutical industry addiction. And then they do it all over again. What medications / drugs do you take? Why? What are the details of the clinical trials? Was the pharmaceutical company fined? What were the overall health outcome for you including the side effects and the drugs for the side effects?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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