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Super super fast delivery, items as described, great partner and communication, A+++, love ordering from this seller!!!! They believe: the customer is king!! A diet pill taken by millions of patients over the past two decades is backed by problematic clinical trials that “systematically underestimated” the drug’s potential harm, according to a new analysis. Danish researchers who reviewed data summaries and published journal articles found that seven drug trials funded by drug manufacturer Roche in the 1990s downplayed the frequency of apparent side effects such as diarrhea or incontinence.
The drug, known to researchers as Orlistat and marketed in the US
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The analysis highlights “something that doctors often suspect: that the reporting of adverse events in clinical trials does not tell the whole picture,” said Dr. Raj Padwal, a clinical pharmacologist and internist at the University of Alberta, who was not involved in Analysis.
The new research, published Tuesday in PLOS Medicine, did not examine data reports submitted to the Food and Drug Administration when Orlistat was approved, first in 1999 as a prescription drug sold by Roche as Xenical or later as a low-dose. , over-the-counter pill sold by GlaxoSmithKline as Alli. (However, the FDA has reviewed the data from the trials in question.)
These trials, conducted in the 1990s by researchers in academic or medical centers, resulted in journal articles. To assess the thoroughness of the articles, Danish researchers compared them with data summaries sent to European regulators, which were obtained through submission of Freedom of Information Act requests. They found that the publications revealed only a fraction, between 14 and 33 percent, of patients’ reported “adverse events” compared to data summaries.
For example, two publications apparently omitted side effects that occurred in less than 5% of test participants; Another considered multiple reports from the same patient as a single adverse event.
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Two other papers, which currently appear on Ali’s website as evidence of the drug’s safety and effectiveness, are also problematic. One reported only apparent side effects considered “common”; The other omitted reports of clear side effects that were not at least twice as common among trial participants taking the drug as among those taking the placebo.
Anja von Treskow, a spokeswoman for Roche, said the test reports “were carried out according to the standards of the time” and that the company was “constantly updating our methods” to meet changing standards.
Joanmarie Goddard, a spokeswoman for Alice’s marketer GlaxoSmithKline, said the company “takes reports of adverse events for our products very seriously and regularly monitors safety information in collaboration with health professionals and regulatory agencies worldwide.”
In the first year after Roche introduced Xenical on the American market, the drug in the United States brought in 600 million dollars worldwide. In the 2000s, the drug was prescribed 11,000,000 times in the United States, according to an analysis of data by the consumer group Public Citizen. When GSK launched the over-the-counter drug as Alli in 2007, it flew through the doors, selling $155 million in its first few weeks on the market.
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The substance, which is intended to be combined with diet and exercise, works by preventing the body from absorbing fat. But the excretion of a lot of fat makes the stool greasy, which causes the gastrointestinal side effects for many patients.
Even at the height of the fabric, the warning signs are clear. The prescription for Xenical declined every year. A 2007 study of nearly 17,000 patients found that only 6 percent of participants were still taking Xenical after a year; After two years it fell to 1 percent.
This is an indication that “the balance between effectiveness and harm is not very favorable,” said Dr. Jeppe Schroll, lead author of the new analysis and researcher at the Nordic Cochrane Center in Copenhagen.
Then in 2010, the FDA added a warning to Xenical and Alli warning of “rare reports” of liver damage; A 2012 study found toxicity effects so alarming that the researcher immediately reported his findings to the FDA.
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Roche no longer markets Xenical in the United States, although generic versions of the prescription drug are still available. GSK no longer breaks down sales of Alli in its financial reports and will not comment on current sales figures for the drug. A pack of 120 Alli pills sells online for $56.
Despite Orlistat’s struggles, drugmakers aren’t giving up on the pill. A Canadian pharmaceutical company, M Pharmaceutical, is working on a reformulated alternative that avoids the socially unacceptable “underwear problems” of the existing drug.
The Danish researchers noted that space limitations in journals may have played a role in what was revealed, and that data reporting standards that have since evolved may make their findings less applicable to newer drugs.
Dr. Rohan Khera, a cardiology fellow at UT Southwestern Medical Center who has studied the effectiveness of various weight-loss drugs, called the new analysis “a good start to determine that we need to study this in more detail.”
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Dr. Sidney Wolff, a consumer advocate for Public Citizen, which unsuccessfully appealed to U. “If you’re a doctor and you rely on medical journals, you can be misled. Doctors do not have time to read the real raw data,” he said.
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Side effects are part of the reason GlaxoSmithKline’s Alli, the first over-the-counter diet pill, works for people who take it. Richard Drew / App
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When the fat blocker Alli hit pharmacy shelves last June, hopeful consumers sought the first government-approved over-the-counter weight loss drug. But it did not take long, and the lack of real weight loss for some, convinced many dieters that Ali is not the only answer to their weight problems.
In addition to Alli, there are about six prescription medications for weight loss
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