FDA Failed to Make Sure Opioid Prescriptions Were Safe, Documents Show
The FDA has the ability to place tight restriction on opioid distribution, but it has dragged its feet in doing that. Scharvik / iStock / Getty Images Plus
The U.S. Food and Drug Administration (FDA) failed to use its regulatory power meant to protect consumers to make sure that a program meant to stop improper prescribing of opioids was effective, according to a new study published in JAMA Internal Medicine.
The researchers found that the weak oversight occurred just as the opioid crisis was taking root and tens of thousands of people were dying from overdoses every year, according to The New York Times.
The researchers at the Johns Hopkins Bloomberg School of Public Health looked at nearly 10,000 pages of FDA documents about the agency's "risk evaluation and mitigation strategy," which it launched in 2012 to address the risks that accompanied extended-release and long-acting opioids, as CNN reported.
Although these drugs "can be clinically useful among appropriately selected patients, they have also been widely oversupplied, are commonly used nonmedically, and account for a disproportionate number of fatal overdoses," the authors wrote, as CNN reported.
The FDA did ask the makers of OxyContin and other highly addictive long-acting painkillers for safety training for the more than half the physicians prescribing the opioids in 2011. The FDA also asked the drug makers to track the efficacy of their training and steps they are taking to reduce addiction and overdoses, as The New York Times reported. However, the FDA was never able to determine if their request was effective because the drug makers failed to collect the proper data.
The researchers found that when the FDA realized through its own review that it was apparent the drug makers were not tracking their training regimen correctly, the agency still did not demand improvement to the risk evaluation and mitigation strategy program, as The New York Times reported.
The study found that after more than five years after implementation, the FDA had no ability "to assess whether these outcomes were achieved," as CNN reported.
"What's surprising here is the design of the program was deficient from the start," said Caleb Alexander, the senior author of the study, who serves as a paid expert witness in litigation against opioid manufacturers and distributors, according to The New York Times. "It's unclear why the FDA didn't insist upon a more scientifically rigorous evaluation of this safety program."
The FDA was aware that allowing the drug companies to fund the analysis of their training was providing insufficient and missing data. A 2013 inspector general report said the agency "lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety." Furthermore, a 2016 FDA advisory committee "noted methodological concerns regarding these studies," according to the authors, as CNN reported.
The study found that the agency is a ripe target for criticism after refusing to take swift and effective action as a crisis was growing.
"FDA has tools that could mitigate opioid risks more effectively if the agency would be more assertive in using its power to control opioid prescribing, manufacturing, and distribution," said retired FDA senior executive William K. Hubbard in an editorial that accompanied the study, as CNN reported. "Instead of bold, effective action, the FDA has implemented the Risk Evaluation and Mitigation Strategy programs that ... do not even meet the limited criteria set out by the FDA."
Hubbard continued that the FDA has the ability to place tight restriction on opioid distribution, but it has dragged its feet in doing that, as CNN reported.Other critics of the government's response to opioid crisis echoed Hubbard's sentiments. Andrew Kolodny, the co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis, told The New York Times that the risk evaluation and mitigation strategy program was "a really good example of the way FDA has failed to regulate opioid manufacturers. If FDA had really been doing its job properly, I don't believe we'd have an opioid crisis today."
Typhoon Molave is expected to make landfall in Vietnam on Wednesday with 90 mph winds and heavy rainfall that could lead to flooding and landslides, according to the U.S. Embassy and U.S. Consulate in Ho Chi Minh City. To prepare for the powerful storm that already tore through the Philippines, Vietnam is making plans to evacuate nearly 1.3 million people along the central coast, as Reuters reported.
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A stretch of coastline in the Philippine capital, Manila has received backlash from environmentalists. The heavily polluted Manila Bay area, which had been slated for cleanup, has become the site of a controversial 500-meter (1,600-foot) stretch of white sand beach.
Sand Makeup Crucial for Ecosystems<p>While UNEP/GRID-Geneva generally supports finding <a href="https://www.dw.com/en/not-enough-sand-for-construction-industry-despite-abundance/a-49342942" target="_blank" rel="noopener noreferrer">alternative sources of sand</a> so as not to disrupt ecosystems in rivers and oceans when extracting them, Vander Velpen stressed it was vital to use sand which closely matches the makeup of the native sand to protect beach fauna.</p><p>"If you change the core characteristics of the native sand, the original sand, you need to do an environmental impact assessment (EIA) to find out how it's going to impact the ecosystem and nearby ecosystems," he told DW.</p><p>But according to Torres, such an assessment was not done in Manila.</p>
Beautification Stunt Instead of Proper Cleanup?<p>Manila Bay's waters are heavily polluted by oil and trash from nearby residential areas and ports. A huge "No swimming" sign warns visitors to stay away from the ocean.</p><p>Philippines' <a href="https://denr.gov.ph/index.php/priority-programs/manila-bay-clean-up/25-priority-programs/1825-frequently-ask-questions-faqs-on-the-dolomite-and-the-beach-nourishment-project" target="_blank">Department of Environment and Natural Resources (DENR)</a> has denied dolomite sand poses any risk to human health and the ecosystem.</p><p>However, scientists of the University of the Philippines have come forward disputing the DENR's claims. A <a href="https://biology.science.upd.edu.ph/index.php/ib-statement-regarding-dolomite-in-manila-bay/" target="_blank" rel="noopener noreferrer">statement by the Institute of Biology</a> said that using crushed dolomite did not address any of the rehabilitation phases and instead was "even more detrimental to the existing biodiversity as well as the communities in the area," pointing to the case of water birds. "The dumping of dolomite in Manila Bay has effectively covered part of the intertidal area used by the birds thereby reducing their habitat."</p><p>At peak migration season, Manila Bay is home to 90 aquatic bird species, including species of international conservation concern that are facing a very high extinction risk in the wild. </p><p>Authorities should focus on protecting and conserving biodiversity, the Institute of Biology added. "Rehabilitating mangroves is an example of a nature-based solution that is cheaper and more cost-effective than the dolomite dumping project," the scientists said.</p><p>Moreover, <a href="http://www.msi.upd.edu.ph/" target="_blank" rel="noopener noreferrer">the Marine Science Institute</a> has warned that prolonged inhalation of finer dust particles of dolomite could "cause chronic health effects," leading to discomfort in the chest, shortness of breath and coughing.</p><p>They also warned dolomite sand grains would erode during storms and be carried out to sea, essentially being washed away.</p>
Rehabilitation vs. Reclamation<p>Environmentalists say covering up the beach doesn't address the real issues of the bay. Torres and others believe the best way to clean up Manila Bay is not to add anything, but rather remove trash and pollution.</p><p>"There have been studies saying much of the waste comes from already collected waste — so these are open dump sites along the coast that get washed up because of the rain," Torres said.</p><p>She criticized the authorities for continuing to push reclamation projects she says are at odds with each other. These projects will affect large areas of mangrove forests, she said, and experts warn that this, in turn, exacerbates coastal erosion.</p><p>"If you've removed the areas that helped trap the sand, like mangrove forests, then the likelihood increases that you will have to nourish a beach. Same as building right up to the waterfront," said Vander Velpen of UNEP/GRID-Geneva.</p>
Plenty of Sand in the Sea?<p>The question of Manila's contentious white beach echoes larger questions about sand mining worldwide. <a href="https://unepgrid.ch/storage/app/media/documents/Sand_and_sustainability_UNEP_2019.pdf" target="_blank">Global sand consumption has tripled</a> over the past two decades, UNEP/GRID-Geneva has found. A huge chunk of it is now taken up by construction.</p><p>"Many operate on the assumption that natural sand is endless in its supply," said Vander Velpen.</p><p>Sand scarcity is a concern shared by Stefan Schimmels of <a href="https://www.fzk.uni-hannover.de/fzk_start.html?&L=1" target="_blank">Forschungszentrum Küste</a> who's done extensive research on shore nourishment to stop coastal erosion. And as climate change and rising sea levels are threatening coasts, demand for sand will grow even more.</p><p>A large study, the <a href="http://www.stencil-project.de/wp-content/uploads/2019/10/STENCIL_SWOT_Analyse_191026.pdf" target="_blank">Strategies and Tools for Environment-Friendly Shore Nourishments as Climate Change Impact Low-Regret Measures (STENCIL project)</a>, focused on the German island of Sylt, a popular vacation spot.</p><p>About 1 million cubic meter of sand per year is used to maintain the coastal area of Sylt, STENCIL project head Schimmels said. That's about 100 million 10-liter buckets of sand.</p><p>When sand was extracted off the coast of Sylt, underwater craters were formed. "You can still detect these craters even decades later," Schimmels told DW.</p><p>"Also when you add a couple of meters sand onto the beach — you essentially bury all things that do creep and fly," he said. "How quickly will they recover?" Schimmels said more research was needed as there was still too little known about long-term effects on the environment. </p>
Criticism Piling Up<p>As for Manila's artificial white sand, it looks like some might have already been blown away by a recent storm. DENR claims it wasn't washed away, but said that grayish sand, stones and other material had simply piled up over the dolomite sand. People in Manila have tweeted photos showing how the storm has ravaged the beach. </p>
<div id="adc0b" class="rm-shortcode" data-rm-shortcode-id="98f9390db6bb81cb421aaf0bb9d9a6fb"><blockquote class="twitter-tweet twitter-custom-tweet" data-twitter-tweet-id="1318816633280851969" data-partner="rebelmouse"><div style="margin:1em 0">Exactly one month after giving excited netizen a glimpse of Manila Bay white sands, look what happened now after ju… https://t.co/X0Z9i0bPB0</div> — M*A*S*H (@M*A*S*H)<a href="https://twitter.com/Magtira_Matibay/statuses/1318816633280851969">1603265362.0</a></blockquote></div><p>Authorities have been called tone-deaf for spending around 389 million pesos ($8 million) on a beach nourishment project in the middle of a raging pandemic.</p><p>An image of cake iced with the words "It really hurts - that's [worth] 389 million pesos?" has since gone viral.</p>
<div class="rm-shortcode" data-rm-shortcode-id="4387aad52ea316e4db7330052318ca2f"><div class="fb-post" data-href="https://www.facebook.com/theweekendpatisserie/posts/144564207350008"></div></div><p>"It's just a waste of precious resources," Torres said. </p><p>The environmental activist now also worries that she might be labeled a terrorist for speaking out under the <a href="https://www.dw.com/en/philippine-anti-terrorism-law-triggers-fear-of-massive-rights-abuses/a-53732140" target="_blank" rel="noopener noreferrer">Philippines' controversial new anti-terrorism law</a>. She says she could be arrested for inciting fear when talking about environmental dangers.</p>
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