Showing posts with label Medical Studies. Show all posts
Showing posts with label Medical Studies. Show all posts

21 August 2008

HEALTH : The Homeopathic Crowd Meets Academic Medicine

Echinacea purpurea: Academic studies say it doesn't work.

'To dismiss alternative medicine too quickly is to miss a central question: What is the role of health care?'
By Kent Sepkowitz

Few things rankle doctors more than alternative (aka complementary, integrative, holistic, homeopathic, naturopathic) medicine. First came the misery inflicted by the ever-expanding celebrity of practitioners like Andrew Weil and Gary Null (and, for a while, even Radovan Karadzic). And now there is the arrival at the NIH feeding trough of the alternative medicine crowd, angling for a mouthful of the same research dollars that currently fund investigations like "the structural basis for translation termination on the 70S ribosome."

Though initially caught flat-footed, academic medicine rallied, as it always does when big bucks are on offer. After decades of belittling the alternative folk as a bunch of snake-oil salesmen and sleazeballs, academic medical centers suddenly realized that—guess what—they were big fans of the approach all along. Yale University is one of the latest brand-name institutions to go through the change. Last year, it joined 40 other medical schools in the Consortium of Academic Health Centers for Integrative Medicine, and began the awkward dance that has characterized such mergers.

Viewed one way, the migration of alternative medicine to the academic mainstream is a fine example of the might of popular will. After all, a 2004 survey revealed that 36 percent of adults in the United States have used alternative medicine at one time or another. If megavitamins and prayer are included, the proportion rises to 62 percent.

A darker view, though, is held by hard-core old-schoolers. Some of their objections are hyperventilation: They massage people! To make theme feel better! More seriously, they cast the encroachment of alternative medicine onto academic turf as a threat to American health because it's diverting money for research and care from traditional approaches. For the last six years, alternative medicine has received about 1 percent of the $28 billion annual NIH budget, or $300 million a year. That's the same amount that efforts to combat stroke, improve food safety, and further develop gene therapy each receive. A Brit, lamenting a similar resource shift in his country, has equated this to murder, writing that had money "spent on refurbishing the Royal Homeopathic hospital" been used instead for effective though expensive drugs to treat breast cancer, hundreds of lives a year would be saved.

Who should prevail in this struggle between naturalistic healers and ass-kickers with syringes full of chemotherapy? In a sense, neither side. Both have much to offer and plenty to be embarrassed about. To date, neither has established an all-encompassing operation so wondrous that it should demand monogamy from patients. So far, though, the problem with pairing the two disciplines at your corner medical center is that it mostly serves to diminish each: The West looks spent and flabby, a bully gone to seed, while the East seems like a kid with a new car and no clue how to drive.

The enforcers of the Western orthodoxy are the preening evidenced-based medicine crowd, those notorious killjoys who operate on the almost amusing premise that every square inch of medicine is built upon reason, the product of a rationally ordered stainless-steel world. If no evidence, they insist, then no truth. And if no truth, get thee out of my medical center. They briskly have swept away the entire alternative field, viewing chelation, St. John's wort, and music therapy, for example, as interchangeably absurd.

But to consider the issue more closely, we have to define alternative medicine with greater care. A 2004 government report divided the field into four big pieces: 1) biologically based practices, including herbs, special diets, and megavitamins; 2) energy medicine, which embraces the concept of magnetic fields; 3) manipulative and body-based practices such as massage and yoga; and 4) mind-body medicine, including prayer and meditation.

Costly attempts to demonstrate efficacy, paid for with taxpayer dollars, have been launched in each of the four areas. To date, as recently detailed, the results have been awful. Take the example of echinacea, an herb used by 40 percent of all natural product gobblers, who take it to ameliorate the symptoms of the common cold. Echinacea was rushed into numerous clinical trials. The result: The research shows that it doesn't work. Or even sort of work.

Rather than admit that they're discouraged or embarrassed by this cold, hard evidence, the alterna-crowd has claimed (OK, whined) that academic-type studies by definition are stacked against them. They consider the bedrock of Western medicine—the randomized, placebo-controlled, double-blind clinical trial—too hard-edged and difficult to implement, just the sort of cruel-hearted gaming of people and disease that so characterizes most things Western. With echinacea and other botanicals, they make the additional complaint that the various trials used the wrong preparation of the magic herb. This problem is indeed critical and slows the pace of assessing various alternative remedies. Unlike standard pharmaceuticals, the production of which is fiercely regulated (another example of the sharp-elbowed West), production of echinacea and its cousins is more laid back. This helps the producer who can sell his wares with little interference, but it's a bit of a nightmare when it comes to mounting a costly clinical trial. If one guy's preparation does or doesn't work, does that mean another echinacea will or won't work, too? The looseness of the alternative approach is part of its appeal—but also hinders it from finding sure footing in the academic realm.

At the same time, to dismiss alternative medicine too quickly is to miss a central question: What is the role of health care? Is the enterprise aimed only at preventing and treating illness, or should it also try to make us feel better? Treating an illness Western-style can mean chopping off a leg, giving chemotherapy, hooking someone up to dialysis. All of this is done to score the touchdown of American medicine: extension of survival by a week, a month, a year, anything. No doctor wants a patient to suffer, but in the Western view the long-term goal of survival comes first. The focus of many Eastern approaches, on the other hand, is on feeling better now rather than lasting longer. And this is something altogether different.

The two goals—treatment and prevention on the one hand and making patients feel better on the other—really are often at odds. And in the future, they surely will diverge further as Western medicine becomes even more technologically sophisticated. A treatment with stem-cell or gene therapy isn't going to be like drinking a glass of orange juice in the morning. The disruption and discomfort the therapies likely will inflict may make today's medicine seem mild. The best response to the über-tech may be an equal and opposite move toward the more benign alternative realm.

Alternative medicine needs money and many years to find its way, and despite the early setbacks for echinacea and other treatments, it would be a mistake to call off the federal investment. Such an absolutist stance ignores the observations of thousands of people over thousands of years as well as the true pace of medical progress, which is at best herky-jerky and aimless. That's not to say that alternative medicine is the equal of Western medicine, or will prove to be, many millions of research funds later. As Steve Jobs discovered, a special organic diet will not cure pancreatic cancer, whereas a six-hour surgery might. As brutal as Western medicine is, it remains a wonder of the modern world. So let's hope that the two sides can find room for each other: The West needs the East's soothing calm to round out its prickliness, while the East needs the West's thuggish urge to push ahead and prove results. I think that's called yin and yang.

Source / Slate / Posted August 13, 2008

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24 July 2008

HEALTH CARE : Bone Density Drugs Can Do More Harm Than Good


Big Pharma Pushes Drugs That Cause Conditions They Are Supposed to Prevent
By Martha Rosenberg / July 24, 2008.

Yet again, women are the industry's main targets.
Like gastroesophageal reflux and bipolar disease, osteopenia began to inflict millions when a drug to treat it was patented.

"Osteopenia, or the risk of developing osteoporosis, was concocted as a disease at a World Health Organization osteoporosis conference in Rome in 1992 that was sponsored by two drug companies and a drug company foundation," writes Susan Kelleher in the Seattle Times.

Using the bone density measurements or "T scores" of a 30-year-old woman as a standard, the new condition, osteopenia, had "boundaries so broad they include more than half of all women over 50," writes Kelleher. And it didn't hurt that 10,000 bone density measuring machines appeared in doctors' offices to detect the new disease -- only 750 existed in 1995 -- many owned and financed by Merck, whose anti-bone-thinning drug Fosamax came online in 1995.

No wonder doctor visits for thinning bones increased by 5 million from 1994 to 2003, according to the Associated Press.

Of course, selling "prevention" to at-risk patients is a pharma gold mine.

It keeps patients on meds for decades through fear, alarmist marketing and after-this-because-of-this reasoning -- since a patient doesn't know if she would have gotten the disease anyway.

So even when reports of Fosamax-related jaw problems called osteonecrosis surfaced -- 1,000 cases have been documented -- and even when a study in the Archives of Internal Medicine this year found that Fosamax doubled women's risk of irregular heartbeat, which can cause clots and strokes, few doubted its primary action of protecting women's bones.

But now, like hormone replacement therapy, which also exploited women's fear of aging and social marginalization, Fosamax appears to cause the conditions it's supposed to prevent.

Since 2006, articles in the New England Journal of Medicine, Journal of Orthopedic Trauma, Journal of Bone and Joint Surgery, Journal of Clinical Endocrinology & Metabolism and Aging Clinical and Experimental Research have suggested the anti-bone turnover action of bisphosphonate drugs like Fosamax can in some cases cause fractures.

Oops.

While preventing bone loss that is caused by the process of bone turnover or remodeling, bisphosphonate drugs can fossilize and petrify a bone so it breaks spontaneously and with minimal trauma -- like chalk. It will not heal properly.

Thighbones of patients on bisphosphonates have "simply snapped while they were walking or standing," following "weeks or months of unexplained aching," reports the New York Times.

Like other fast-tracked-to-Wall-Street drugs that are effectively "tested" on the first users, adverse reports about bisphosphonates came from patients and practitioners long before they came from the FDA or manufacturers.

Bisphosphonate patients have documented excruciating pain from Fosamax since 2001 and GlaxoSmithKline's Boniva since 2006 on askapatient.com, many calling the drugs "poison" and saying they were forced into wheelchairs.

But only in March did the FDA alert health care professionals to the "severe, sometimes incapacitating, musculoskeletal pain" that bisphosphonate drugs could cause in their patients and caution them to consider whether musculoskeletal pain "might be caused by the drug" rather than the bone condition.

Not only is the pain that bisphosphonate patients report "not in their heads" -- imagine 1,257 men on askapatient.com saying their doc dismissed their constant pain and symptomology -- it is emblematic of what is really going on.

"There is actually bone death occurring," Dr. Phuli Cohan told Mallika Marshall, M.D., a medical reporter for Boston's WBZ-TV News in May. "People don't want to believe that this is happening, but it is a side effect of the medicine," she said.

Dr. David Hunter of New England Baptist Hospital concurs that bisphosphonates can cause "dead bone syndrome" and that patients should have a "drug holiday to allow bone cells to rejuvenate," reports Marshall.

Even drug reps on the industry chat room cafepharma are skeptical about bisphosphonates.

"They over-suppress the bone and 'may' cause subtrochanter fractures. ... It's the next hot button," wrote one anonymous poster on a thread titled "Is Boniva dead?" sparked by a rumor that Boniva pitchwoman Sally Fields had fallen and broken a bone.

Nor do bisphosphonates exit the body quickly when patients quit taking them, according to a 2006 study in the Journal of the American Medical Association -- rather, they remain for years.

(Patients "need not take costly bone-building drugs such as Fosamax for life to reap the medicine's protective benefits," was the News & Observer's upbeat interpretation of the drug's tenacity.)

Will bisphosphonates be the next hormone replacement therapy? Another example of women getting the diseases they were supposed to avoid, thanks to misogynistic marketing?

Is there a market for 10,000 used bone density measuring machines?

Source / AlterNet

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14 July 2008

HEALTH CARE : Do Cholesterol Drugs Do Any Good?

Graphic courtesy of Pharma Marketing.

Statins: Looking at the stats
By Duncan Echelson
/ The Rag Blog / July 14, 2008

Statin pharmaceuticals are marketed ferociously on TV ads and by many MD's. The statins are major money makers for the pharmaceutical companies. For relatively small groups of specific types of patients the real research shows some benefit but for most of the patients taking statins it is based on conjecture, not research.

Not only is there no proven benefit for many of the people taking
statins, there are some rather significant side effects such as severe
muscle pain, memory loss and sexual dysfunction.

There are more than 18 million Americans taking statins and worldwide sales totaled more than 33 billion dollars in 2007.

The history of statins and cholesterol theory make a very interesting
case study of the pharmaceutical and medical industries and is well
worth studying, in order to learn how we can avoid being manipulated
for power and profit.

Just as interesting is learning how medical science can be led into
taking positions that are based on political maneuvering and sloppy
data analysis rather than science.

You might be one of the 18 million people taking statins and if not, I
am sure that you know people who are (friends, siblings, parents). If
so, then please read the series of pieces so you can ask questions,
find answers and make decisions as to whether taking statins is really
a benefit or if it is a danger waste of your health dollars and
efforts.

For step one, in our investigation, I offer you a very well written and referenced article from the Jan. 17, 2008 issue of Business Week magazine. Please note this is only step one of a series of articles and documents to help us understand. The source of this article is surprising but I guarantee you will find it very interesting.
Duncan Echelson is a licensed Acupuncturist/Herbalist who can be found at Oak Hill Oriental Medicine in Austin. His focus is helping people become healthier. He particularly enjoys teaching people simple ways to maintain and improve their health.

He has great respect for those physicians who truly live by the Hippocratic oath and for those researchers who are dedicated to understanding their study subjects without fear or favor.

In addition, he knows of many cases where the judicious use of pharmaceuticals and medical procedures have been very important for treating disease and trauma.

It is the misuse of pharmaceuticals, medical techniques, and research studies that he finds deeply offensive and drives him to keep up with news and analysis of these fields.

He welcomes comments, favorable or critical. Leads to stories in medicine and pharmaceutical are also welcome.

You can reach him at duncanechelson@gmail.com.
Do Cholesterol Drugs Do Any Good?

Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated
By John Carey

Martin Winn's cholesterol level was inching up. Cycling up hills, he felt chest pain that might have been angina. So he and his doctor decided he should be on a cholesterol-lowering medication called a statin. He was in good company. Such drugs are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer (PFE) for its leading statin, Lipitor. Statins certainly performed as they should for Winn, dropping his cholesterol level by 20%. "I assumed I'd get a longer life," says the retired machinist in Vancouver, B.C., now 71. But here the story takes a twist. Winn's doctor, James M. Wright, is no ordinary family physician. A professor at the University of British Columbia, he is also director of the government-funded Therapeutics Initiative, whose purpose is to pore over the data on particular drugs and figure out how well they work. Just as Winn started on his treatment, Wright's team was analyzing evidence from years of trials with statins and not liking what it found.

Yes, Wright saw, the drugs can be life-saving in patients who already have suffered heart attacks, somewhat reducing the chances of a recurrence that could lead to an early death. But Wright had a surprise when he looked at the data for the majority of patients, like Winn, who don't have heart disease. He found no benefit in people over the age of 65, no matter how much their cholesterol declines, and no benefit in women of any age. He did see a small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials. But even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalization—despite big reductions in "bad" cholesterol. "Most people are taking something with no chance of benefit and a risk of harm," says Wright. Based on the evidence, and the fact that Winn didn't actually have angina, Wright changed his mind about treating him with statins—and Winn, too, was persuaded. "Because there's no apparent benefit," he says, "I don't take them anymore."

Wait a minute. Americans are bombarded with the message from doctors, companies, and the media that high levels of bad cholesterol are the ticket to an early grave and must be brought down. Statins, the message continues, are the most potent weapons in that struggle. The drugs are thought to be so essential that, according to the official government guidelines from the National Cholesterol Education Program (NCEP), 40 million Americans should be taking them. Some researchers have even suggested—half-jokingly—that the medications should be put in the water supply, like fluoride for teeth. Statins are sold by Merck (MRK) (Mevacor and Zocor), AstraZeneca (AZN) (Crestor), and Bristol-Myers Squibb (BMY) (Pravachol) in addition to Pfizer. And it's almost impossible to avoid reminders from the industry that the drugs are vital. A current TV and newspaper campaign by Pfizer, for instance, stars artificial heart inventor and Lipitor user Dr. Robert Jarvik. The printed ad proclaims that "Lipitor reduces the risk of heart attack by 36%...in patients with multiple risk factors for heart disease."

So how can anyone question the benefits of such a drug?

For one thing, many researchers harbor doubts about the need to drive down cholesterol levels in the first place. Those doubts were strengthened on Jan. 14, when Merck and Schering-Plough (SGP) revealed results of a trial in which one popular cholesterol-lowering drug, a statin, was fortified by another, Zetia, which operates by a different mechanism. The combination did succeed in forcing down patients' cholesterol further than with just the statin alone. But even with two years of treatment, the further reductions brought no health benefit.

Doing the Math

The second crucial point is hiding in plain sight in Pfizer's own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says: "That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor."

Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.

Compare that with, say, today's standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.

A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out.

Plus, there are reasons to believe the overall benefit for many patients is even less than what the NNT score of 100 suggests. That NNT was determined in an industry-sponsored trial using carefully selected patients with multiple risk factors, which include high blood pressure or smoking. In contrast, the only large clinical trial funded by the government, rather than companies, found no statistically significant benefit at all. And because clinical trials themselves suffer from potential biases, results claiming small benefits are always uncertain, says Dr. Nortin M. Hadler, professor of medicine at the University of North Carolina at Chapel Hill and a longtime drug industry critic. "Anything over an NNT of 50 is worse than a lottery ticket; there may be no winners," he argues. Several recent scientific papers peg the NNT for statins at 250 and up for lower-risk patients, even if they take it for five years or more. "What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? How many would take that?" asks drug industry critic Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles.

Drug companies and other statin proponents readily concede that the number needed to treat is high. "As you calculated, the NNT does come out to about 100 for this study," said Pfizer representatives in a written response to questions. But statin promoters have several counterarguments. First, they insist that a high NNT doesn't always mean a drug shouldn't be widely used. After all, if millions of people are taking statins, even the small benefit represented by an NNT over 100 would mean thousands of heart attacks are prevented.

That's a legitimate point, and it raises a tough question about health policy. How much should we spend on preventative steps, such as the use of statins or screening for prostate cancer, that end up benefiting only a small percentage of people? "It's all about whether we think the population is what matters, in which case we should all be on statins, or the individual, in which case we should not be," says Dr. Peter Trewby, consultant physician at Darlington Memorial Hospital in Britain. "What is of great value to the population can be of little benefit to the individual." Think about buying a raffle ticket for a community charity. It's for a good cause, but you are unlikely to win the prize.

Statin proponents also argue that when NNTs are calculated after the drugs have been taken for just three or five years, they're misleadingly high. Pfizer says that even though only one heart attack was prevented per 100 people in its trial, "it may be a possibility that several or even all [100] benefit" by reducing their risk of a future heart attack. And the benefit grows when the drugs are taken for more years, backers believe. "It does not make sense to take a statin for five years," says Dr. Scott M. Grundy, chair of the NCEP committee that called for more aggressive statin treatment and director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas. "When you take a cholesterol-lowering drug, it is a huge commitment," he says. "You take it for life." Grundy figures the chances of having a heart attack over the course of a lifetime are about 30% to 50% (higher for men than women). Statins, he argues, reduce that risk by about 30%. As a result, taking the drugs for 30 years or more would bring 9 to 15 fewer heart attacks for every 100 people. So only 7 to 11 people would have to take the drugs for life for one to benefit.

Critics reply that this rosier picture requires several leaps of faith. A 30% reduction in heart attacks "is the best-case scenario and not found in many of the studies," says Wright. What's more, statins have been in use now for 20 years, and there's little evidence yet that the NNT decreases the longer people take the drug. Most important, the statin trials of people without existing heart disease showed no reduction in deaths or serious health events, despite the small drop in heart attacks. "We should tell patients that the reduced cardiovascular risk will be replaced by other serious illnesses," says Dr. John Abramson, clinical instructor at Harvard Medical School and author of Overdosed America.

Read the rest of this article here. / Business Week

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01 July 2008

Medical Study on Psilocybin : Lasting Positive Effects

'Shrooms.

Heck, they could have just asked us...

Magic Mushrooms produce long-term
sense of well-being

By John Lazarou / July 1, 2008

In a follow-up to research showing that psilocybin, a substance contained in "sacred mushrooms," produces substantial spiritual effects, a Johns Hopkins team reports that those beneficial effects appear to last more than a year.

Writing in the Journal of Psychopharmacology, the Johns Hopkins researchers note that most of the 36 volunteer subjects given psilocybin, under controlled conditions in a Hopkins study published in 2006, continued to say 14 months later that the experience increased their sense of well-being or life satisfaction.

"Most of the volunteers looked back on their experience up to 14 months later and rated it as the most, or one of the five most, personally meaningful and spiritually significant of their lives," says lead investigator Roland Griffiths, Ph.D., a professor in the Johns Hopkins departments of Psychiatry and Behavioral Sciences and Neuroscience.

In a related paper, also published in the Journal of Psychopharmacology, researchers offer recommendations for conducting this type of research.

The guidelines caution against giving hallucinogens to people at risk for psychosis or certain other serious mental disorders. Detailed guidance is also provided for preparing participants and providing psychological support during and after the hallucinogen experience. These "best practices" contribute both to safety and to the standardization called for in human research.

"With appropriately screened and prepared individuals, under supportive conditions and with adequate supervision, hallucinogens can be given with a level of safety that compares favorably with many human research and medical procedures," says that paper's lead author, Mathew W. Johnson, Ph.D., a psychopharmacologist and instructor in the Johns Hopkins Department of Psychiatry and Behavioral Sciences.

The two reports follow a 2006 study published in another journal, Psychopharmacology, in which 60 percent of a group of 36 healthy, well-educated volunteers with active spiritual lives reported having a "full mystical experience" after taking psilocybin.

Psilocybin, a plant alkaloid, exerts its influence on some of the same brain receptors that respond to the neurotransmitter serotonin. Mushrooms containing psilocybin have been used in some cultures for hundreds of years or more for religious, divinatory and healing purposes.

Fourteen months later, Griffiths re-administered the questionnaires used in the first study -- along with a specially designed set of follow up questions -- to all 36 subjects. Results showed that about the same proportion of the volunteers ranked their experience in the study as the single most, or one of the five most, personally meaningful or spiritually significant events of their lives and regarded it as having increased their sense of well-being or life satisfaction.

"This is a truly remarkable finding," Griffiths says. "Rarely in psychological research do we see such persistently positive reports from a single event in the laboratory. This gives credence to the claims that the mystical-type experiences some people have during hallucinogen sessions may help patients suffering from cancer-related anxiety or depression and may serve as a potential treatment for drug dependence. We're eager to move ahead with that research."

Griffiths also notes that, "while some of our subjects reported strong fear or anxiety for a portion of their day-long psilocybin sessions, none reported any lingering harmful effects, and we didn't observe any clinical evidence of harm."

The research team cautions that if hallucinogens are used in less well supervised settings, the possible fear or anxiety responses could lead to harmful behaviors.
These studies were funded by grants from NIDA, the Council on Spiritual Practices, and the Heffter Research Institute.

Additional researchers who contributed to this work include Matthew W. Johnson, Ph.D. and Una D. McCann, M.D. of the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine; psychologist William A. Richards of the Johns Hopkins Bayview Medical Center; and Robert Jesse of the Council on Spiritual Practices, San Francisco.
Source. / EurekAlert!

Thanks to Jim Baldauf / The Rag Blog

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