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I dont fing care: In wooing $67M from big alcohol, NIH nixed critical study

Amid that wooing, other researchers claimed for the first time Monday that they were scolded by agency officials for collecting data that appeared critical of the alcohol industry. They also suggest that the agency spiked a similarly critical research proposal, despite that it was highly ranked by scientific peers who evaluate proposals for funding purposes. In a statement last month , NIH Director Francis Collins said that the “NIH will be looking into this matter.” He also told reporters that “there are concerns that... there may have been some inappropriate discussions that went on between people working at NIH unbeknown to me and the beverage industry,” according to The Washington Post . The National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is at the center of the controversy, did not immediately respond to a request for comment from Ars. One of the first sips of scandal dates back to last July when The New York Times reported on the study looking at potential benefits of booze, dubbed the Moderate Alcohol and Cardiovascular Health Trial (MACH). The $100 million-dollar, 10-year study is now underway and will ultimately enroll 7,800 participants aged 50 or over at 16 sites worldwide. Half of the participants will abstain from hooch, while the rest will imbibe one serving a day. Scientists will track participants for an average of six years, looking at risks of heart attacks, strokes, diabetes, and death. The Times article noted that $67.7 million for the study came—indirectly—from five of the world’s largest alcoholic beverage companies, including Anheuser-Busch InBev, Diageo, Pernod Ricard, Heineken, and Carlsberg. The companies pledged the money for the study through a foundation that raises funds for NIH research. Many of the researchers at the receiving end of those funds already had close personal ties and/or financial links to the alcohol industry, the Times article noted. That includes NIAAA Director George Koob, who, for years prior, served on an industry advisory board that also provided him with tens of thousands of dollars in research funding. Koob was dismissive of any conflicts of interest at the time, however, telling the Times: “This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it. The money from the Foundation for the NIH has no strings attached.” But the links and the funding didn’t sit well among the research community, who are all too aware that industry-sponsored research often ends up favoring the interests of industry. Many also noted weaknesses in the study's design, including the short duration that limited “moderate” drinking to one drink rather than the more common two and lumped men and women’s health assessments together. In a subsequent story in Wired from October, researchers again expressed concern, with alcohol researcher Jürgen Rehm of Toronto’s Centre for Addiction and Mental Health telling the magazine that "the way this is set up, it smells." The Wired article also noted that Koob and NIAAA Director of Global Alcohol Research Margaret (Peggy) Murray both appeared in a promotional video for Anheuser-Busch InBev, one of the MACH funders, as the NIAAA was setting up for the trial. The video was about company-sponsored research.

To get the original version this includes any additional graphics or video footage, head to https://arstechnica.com/science/2018/04/i-dont-f-ing-care-in-wooing-67m-from-big-alcohol-nih-nixed-critical-study/

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Dr. Andrew Saxon at the Veterans Affairs Puget Sound Health Care System in Seattle, and Dr. Walter Ling at the University of California, Los Angeles Integrated Substance Abuse Program, conducted the trial with colleagues in the NIDA Clinical Trials Network. Dr. Saxon’s team randomly assigned 1,269 new patients in 8 U.S. opioid treatment programs to therapy with either Bup/Nx or methadone. The study findings reflect the experiences of 731 patients who provided blood samples for liver function tests at baseline, completed the 24 weeks of active treatment, and submitted blood for at least 4 of 8 scheduled tests of liver function during treatment. These tests include measuring the levels of two enzymes (alanine aminotransferase and aspartate aminotransferase) that the liver releases when it is injured. Most trial participants maintained enzyme levels that indicate healthy liver function throughout the study ( see Figure ). In 15.5 percent, enzyme levels increased to higher than twice the upper end of the normal range, indicating some ongoing liver injury. A few patients developed extreme elevations to 10 times the upper limit of normal or had other laboratory signs of severe liver injury. The percentages of Bup/Nx and methadone patients who experienced each outcome were so close as to be statistically equivalent, warranting the conclusion that both medications were similarly safe. Although the researchers could not definitively rule out the possibility that the medications contributed to some of the observed worsening of liver function, their analysis produced no evidence to this effect. Instead, they say the changes most likely resulted from hepatitis, the toxicity of illicit drugs, and impurities in those drugs. Infection with hepatitis B or C doubled a patient’s odds of a significant change in enzyme levels and was the only predictor of worsening liver function. Most extreme increases in enzyme levels occurred when a patient seroconverted to hepatitis B or C, or used illicit drugs during the study. The researchers note that about 44 percent of those screened for the study did not meet its enrollment criteria, suggesting that the participant group was healthier than many who visit clinics for addiction treatment. The ineligible population was also older, had a higher rate of stimulant use, and was less likely to be white than patients in the enrolled group, suggesting that the evaluable patient group might not be representative of all opioid-dependent patient groups. Figure. Researchers See No Evidence for Buprenorphine/Naloxone or Methadone Liver Damage The percentages of trial participants who incurred clinically significant transaminase increases during the study were similar among patients receiving buprenorphine/naloxone or methadone.

https://www.drugabuse.gov/news-events/nida-notes/2013/12/medications-treat-opioid-addiction-do-not-impair-liver-health can alcohol abuse cause psoriasis

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you could try these out alt='Dr Marilyn Huestis' align='left' /> Some have mitochondrial dysfunction, bone resorption—which can lead to bone fractures—growth restriction, or language delay. The goal of our collaboration with PHACS is to understand the relationships between antiretroviral exposure and these adverse outcomes. A prerequisite for reaching this goal is to be able to precisely measure fetal exposure to the medications. The PHACS researchers asked us to develop an assay for a wide spectrum of antiretrovirals in meconium. Meconium is the first stool an infant expels after birth. It is a good matrix for measuring fetal drug exposures, because to be in meconium, a drug has to have passed through the fetus. In contrast, a mother’s drug intake is not a very exact indicator of fetal exposure, because only a limited amount reaches the fetus. We developed a meconium assay that accurately measures levels of 99.2 percent of all the antiretrovirals taken by women in the PHACS study. With the assay now in hand, we are starting a study of one antiretroviral, tenofovir, which has been linked to bone restriction and growth delay. We will measure levels of tenofovir in infants’ meconium, and see if they predict which infants go on to develop those problems. We are also planning a study of atazanavir, which has been associated with language delays. These studies hopefully will enable physicians to identify and provide early interventions to children whose fetal exposure to antiretrovirals has put them at risk for developmental delays. Ultimately, we hope our results will enable physicians to adjust antiretroviral regimens to best protect both mother and child. NN: Do outside groups often contact you, as PHACS did, for technical assistance? Dr. Huestis: Yes, they do. We have about 40 ongoing research collaborations, some of them with NIH intramural groups, but most with extramural scientists from around the samhsa world. We’re working with groups in South Africa to study women who use methamphetamine, cannabis, and tobacco; a group in Uruguay that studies tobacco use in pregnant women; and a group in Scotland that is looking at fetal alcohol exposure. We also have cooperative research and development agreements with pharmaceutical companies to test new drugs. NN: What are some of the biggest challenges you’re facing now?

https://www.drugabuse.gov/news-events/nida-notes/2013/09/q-dr-marilyn-huestis