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Sunday, September 16, 2018

Caspase-2 enzyme inhibitor shows promise against fatty liver disease


Researchers at University of California San Diego School of Medicine have discovered using mice and human clinical specimens, that caspase-2, a protein-cleaving enzyme, is a critical driver of non-alcoholic steatohepatitis (NASH), a chronic and aggressive liver condition. By identifying caspase-2’s critical role, they believe an inhibitor of this enzyme could provide an effective way to stop the pathogenic progression that leads to NASH — and possibly even reverse early symptoms.
The findings are published in the September 13 online issue of Cell.
“Our results show that caspase-2 is a critical mediator of NASH pathogenesis, not only in mice but probably in humans as well,” said Michael Karin, PhD, Distinguished Professor of Pharmacology at UC San Diego School of Medicine. “While explaining how NASH is initiated, our findings also offer a simple and effective way to treat or prevent this devastating disease.”
NASH is the most aggressive form of non-alcoholic fatty liver disease (NAFLD), which includes a spectrum of chronic liver diseases and has become a leading cause of liver transplants. The cause of both NAFLD and NASH remains a mystery, but researchers believe one factor that accelerates the progression of benign NAFLD to aggressive NASH is elevated endoplasmic reticulum (ER) stress, induced by protein misfolding within the liver. This results in excessive buildup of cholesterol and triglycerides in liver tissue.
Applying this premise in mice, researchers first identified molecules involved in NASH pathogenesis by combining liver-specific ER stress and a high-fat diet to elicit NASH like disease, duplicating the cardinal features of human NASH, including fat accumulation in liver cells, liver damage, inflammation and scarring. Using this model, researchers found that the onset of NASH correlated with increased expression of caspase-2.
In the next phase, Karin and team examined human liver specimens collected from patients with benign NAFLD or aggressive NASH to confirm caspase-2 expression was also elevated in humans. By knocking out the caspase-2 gene in mice subjected to liver ER stress and high-fat diet or treating the mice with a specific caspase-2 inhibitor, they found that caspase-2 was responsible for all aspects of NASH, including lipid droplet accumulation, liver damage, inflammation and scarring.
“We now know that by preventing caspase-2 expression or inhibiting its activity that biomarkers of NASH are mitigated,” said Juyoun Kim, PhD, senior fellow in the Karin laboratory and lead author. “This is exciting because now, we not only understand the role of caspase-2 in the disease, but also have a new avenue to find a potential drug treatment.”
Through this study, Karin and team also discovered that caspase-2 has a critical role in activating SREBP1 and 2 — the master regulators of lipogenesis, a process that takes place in the liver where nutrients like carbohydrates are turned into fatty acids, triglycerides and cholesterol. Caspase-2 was found to control SREBP1 and 2 activation by cleaving another protein called site-1 protease.
“In NASH-free individuals, the activities of SREBP1 and SREBP2 are kept under control, which is essential for preventing excessive lipid accumulation in the liver,” said Karin. “However, in NASH patients, something goes awry and the liver continues to turn out excess amounts of triglycerides and cholesterol. This correlates with elevated SREBP1 and SREBP2 activities and increased caspase-2 expression.”
Moving forward, Karin and team would like to embark on development of more effective drug-like caspase-2 inhibitors that could be used for NASH prevention, and ultimately provide a treatment option.
“This study was a great step forward in being able to understand the causes, and explore possible new treatments for patients with NASH and NAFLD,” said co-author Rohit Loomba, MD, director of the UC San Diego NAFLD Research Center and director of hepatology at UC San Diego School of Medicine. “It is our hope to eventually translate and validate these study results using a much larger cohort of human subjects.”
“This study was a great step forward in being able to understand the causes, and explore possible new treatments for patients with NASH and NAFLD,” said co-author Rohit Loomba, MD, director of the UC San Diego NAFLD Research Center and director of hepatology at UC San Diego School of Medicine. “It is our hope to eventually translate and validate these study results using a much larger cohort of human subjects.”
Co-authors include: Ricard Garcia-Carbonell, Shinichiro Yamachika, Peng Zhao, Debanjan Dhar and Alan R. Saltiel, all UC San Diego; and Randal J. Kaufman, Sanford-Burnham-Prebys Medical Discovery Institute.
Story Source:
Materials provided by University of California – San Diego. Original written by Gabrielle Johnston, MPH. Note: Content may be edited for style and length.
Journal Reference:
  1. Ju Youn Kim, Ricard Garcia-Carbonell, Shinichiro Yamachika, Peng Zhao, Debanjan Dhar, Rohit Loomba, Randal J. Kaufman, Alan R. Saltiel, Michael Karin. ER Stress Drives Lipogenesis and Steatohepatitis via Caspase-2 Activation of S1P. Cell, 2018; DOI: 10.1016/j.cell.2018.08.020
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Working with Patients and a Fresh $80M, Fulcrum Eyes a 2019 IPO


Fulcrum Therapeutics, a Cambridge, MA, startup run by the former CEO of Epizyme, has closed an $80 million Series B round that lays the groundwork for a likely IPO next year, its CEO says.
The new funding, led by Foresite Capital, comes from a wide array of crossover investors, such as Fidelity Management and Research, that back both private and public companies. These types of rounds often precede IPOs in biotech, and CEO Robert Gould says that is Fulcrum’s plan. The company hopes to go public early next year, after filing papers with the FDA to begin human testing of its first drug, for a rare muscle wasting disease called facioscapulohumeral muscular dystrophy (FSHD), Gould says.
“We think that the strength of the preclinical data and the quality of the compound is such that it’ll be an attractive investment opportunity,” he says.
That has yet to be proven, but Gould has been here before. The one-time Merck executive helped take cancer drug developer Epizyme (NASDAQ: EPZM) public in 2013, raising about $80 million at $15 a share. He left the company two years later and resurfaced as the CEO of Fulcrum in 2016.
Fulcrum is trying to use drugs to control molecular switches that turn genes on or off, hoping to treat a variety of diseases with no effective treatments—starting with FSHD, which is marked by muscle degeneration that starts in the face, back, and upper arms. Though the disease typically progresses slowly and isn’t fatal, FSHD, which affects an estimated 870,000 people worldwide according to the nonprofit FSH Society, can leave patients in wheelchairs or on respirators. There are ways to help manage the disease’s complications, but no available therapies can halt or reverse its progress. Fulcrum’s experimental drug is meant to “at bare minimum” halt the progression of FSHD by preventing the expression of a protein, DUX4, implicated in the disease, Gould says.
Its scientific aspirations aside, however, Fulcrum is a product, of sorts, of the FDA’s increasing willingness to incorporate patient perspectives throughout the drug development process. Fulcrum reached out to patient groups to figure out which diseases to go after, even before the company was officially formed in 2016. That led it to FSHD. That approach is atypical; more often, drug developers connect with patient groups later on, Michael Tranfaglia, medical director, chief scientific officer, and co-founder of the FRAXA Research Foundation, told Xconomy in 2017.
Fulcrum has worked with the FSH Society, for instance, to obtain muscle tissue samples from people with the disease undergoing surgery as part of their treatment. The company has used those samples to grow muscle cells from the tissue and test its drug candidates against those cells. “It’s a unique relationship,” FSH Society president, CEO and co-founder Daniel Perez told Xconomy last year. (Fulcrum was a finalist for Xconomy’s patient partnership award in 2017.)
Gould says establishing relationships with the patient community has helped Fulcrum get its hands on those samples. The company has also teamed with patient advocacy groups to begin work on various studies, among them a “natural history” study in FSHD to better understand the disease’s trajectory. It’s working with patients to learn how the disease affects their quality of life and what types of benefits from a drug would be valuable. That insight, in turn, should help the company design clinical trials to answer questions that “speak directly to the patient’s needs and desires,” Gould says. And working with patient groups from the outset should help Fulcrum more quickly recruit patients for those studies.
“Just like they can educate us about what’s important for daily life, we can educate them about how vitally important tissue donation is to potentially identifying a therapy for a disease,” Gould says.
Fulcrum started up with a $55 million Series A in 2016 from Third Rock Ventures. The company is also developing drugs for sickle cell disease, Duchenne muscular dystrophy, and Fragile X syndrome.
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With OneOncology, Flatiron and Cancer Docs Aim to Boost Community Care


A number of new technologies, from immunotherapy to targeted medicines and diagnostics, have all helped change cancer care the past few years. But not all cutting-edge technologies are available to patients who seek treatment at smaller clinics.
OneOncology, an unusual new startup being launched this morning, aims to help cancer patients in community settings gain access the latest treatments and learn about clinical trials, as they would if they were at a major medical center.
OneOncology is a new healthcare company formed by three of the nation’s largest community-based cancer practices that see 158,000 patients per year: Tennessee Oncology, New York Cancer & Blood Specialists, and West Cancer Center. The company brings together doctors and patients from these three practices and connects them through the cancer-specific electronic health record (EHR) software developed by Flatiron Health.
For Flatiron, a high-flying New York startup that Roche bought for $1.9 billion in February, OneOncology represents a way to acquire more patient data and customers for its EHR system.
The company is starting up with a $200 million investment from private equity firm General Atlantic. Tracy Bahl, a former CVS Health executive, is president and CEO. Each participating practice has an equity stake.
In an e-mail to Xconomy, Robin Shah, a former Flatiron executive who runs OneOncology’s business development efforts, said the goal of the organization is to “ensure patients receive the same best-class care no matter where they live.”
Shah said OneOncology’s solution involves putting a wide array of community practices on Flatiron’s EHR system, so doctors can share data on a cloud-based system, stay up on the latest research, work through changing drug payment and reimbursement models, and learn from one another. Flatiron’s software collects data that, stripped of patient-identifying information, are sold to drug companies and others to use in either research or clinical trial recruitment. It has partnerships with 275 community cancer clinics nationwide.
According to the Community Oncology Alliance, more than half of U.S. cancer patients are treated at community oncology practices—private, physician-owned businesses that aren’t part of the country’s major cancer centers like Memorial Sloan Kettering in New York or Dana-Farber in Boston. But community doctors don’t have the same resources as those at the big medical centers. Many aren’t up to speed on the latest scientific literature, research, or clinical trials.
“No one person has the bandwidth to use this developing, expanding armamentarium [of drugs] in the best possible way for patients unless they are really focused, and are in a setting where they’re always hearing about the latest clinical trials and results,” Drew Pardoll, director of the Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy, told Xconomy earlier this year.
For instance, newer diagnostic technologies such as DNA tests that scan for a tumor’s genetic alterations may be underutilized in the community setting, says Jens Reuter, medical director of the private nonprofit Maine Cancer Center Initiative. Even when community doctors use the new diagnostics, the complex reports they generate can be difficult to interpret and act upon. What happens, for example, if a test recommends using a cancer drug that isn’t approved for the patient being tested? There’s been a “lack of comprehensive education” for community oncologists, says Rueter.
Shah said with Flatiron’s help, OneOncology will build a “collective platform” to alert participating doctors about ongoing trials.
“Overall, consortia like this make a lot of sense to me,” Reuter says, noting that with bigger scale, community practices will be better able to learn about patients, share treatment insights, and attract clinical trials.
Still, Reuter notes that OneOncology isn’t championing “a precision medicine approach,” that is, sequencing patients’ tumors for a wide range of genetic alterations and using those insights to find a drug. There is much debate within the scientific community as to the benefits of precision oncology—just a few weeks ago, for example, the Journal of the American Medical Association published a paper showing that broad DNA sequencing of the tumors of lung cancer patients in community practices didn’t lead to a survival benefit.
Shah said OneOncology’s community partners will establish guidelines for the use of all types of diagnostic testing, including broad DNA sequencing tests, and get patients access to the latest treatment options. The goal is to standardize treatment across the participating practices and to be a “driver” in “value-based payment models” that tie a drug’s price to its performance. “We believe this will be the future of oncology and healthcare,” Shah said.
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Vision Assistance Startup Aira Inking Deals With UCSD, Retail Stores


Students and shoppers will soon be using technology developed by Aira, a San Diego startup that links vision-impaired people with “visual interpreters” via smartphone and smart glasses, to help them navigate their environments.
In recent weeks Aira announced that its accessibility service would be available at no cost to those who need it while at UC San Diego, in about 5,000 AT&T stores, and at all Wegmans grocery stores. The Rochester, NY-based grocery chain has 97 stores in six East Coast states.
The Aira app links people who are blind or have impaired vision with independent contractors that Aira calls “agents.” Via the app, agents help Aira users with tasks they may otherwise have difficulty managing, from shopping for groceries to reading a restaurant menu. The agents talk to users through the speaker in their phone or smart glasses.
The service is available for individuals via paid subscription; the price of the subscription varies based on how many minutes of assistance are provided. Aira offers four tiers, starting with an $89 monthly plan, which comes with 100 minutes, and topping out at $329 per month for unlimited minutes of assistance. With a subscription comes Aira Smart Glasses.
The recently signed corporate customers, however, will be providing the service free within locations each has identified. At UCSD, that includes the Scripps Institution of Oceanography in La Jolla and its medical campus in Hillcrest. Signing on businesses is a way for the company to more rapidly expand its user base—and increase revenue—as compared to acquiring individual users. That’s the goal, anyway.
CEO Suman Kanuganti founded Aira in 2014 while he was an MBA student at the UCSD Rady School of Management. Among his advisors was the late Larry Bock, a serial entrepreneur who helped start 50 companies, most after he was diagnosed at age 29 with an eye disease that causes progressive loss of vision.
The company’s connection with AT&T is longstanding. The Dallas, TX-based telecom helped Aira develop its service through its Foundry for Connected Health initiative in Houston, which focuses on digital health technologies, and AT&T provides Aira users with dedicated wireless bandwidth.
In 2017 Aira raised a $12 million Series B round to expand its services—which had been tested with about 300 people—to thousands more users. The round was led by San Francisco-based Jazz Venture Partners and Ann Arbor, MI-based Arboretum Ventures. Lux Capital, Arch Venture Partners, and Felicis Ventures also participated, and the National Federation of the Blind joined as a strategic investor.
Aira, previously housed within the Southern California incubator EvoNexus, is based in La Jolla.
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4 Who Predicted Global Financial Crisis; What They Think Causes The Next One

A different kind of hurricane slammed into the American East coast, the nation and ultimately the world ten years ago today.
Amidst the multiple introspective columns and soul searching that naturally occurred this week, which looked back on the missed warning signs behind the 2008 financial collapse exactly a decade ago this weekend, there is a small group of people whose opinions are actually worth paying attention to.
Though arguably no single individual accurately called all aspects of the crisis in its entirety, precipitated by the implosion of Lehman Brothers, some did very publicly predict key facets with prophetic clarity. As Market Watch’s Howard Gold explains in his profile of four analysts the world should have been listening to: “People warned about subprime mortgage loans, derivatives, and too much leverage, but nobody, to my knowledge, said a bursting housing bubble would cause a global crisis that would lead to the demise of venerable financial firms, require trillion-dollar taxpayer bailouts, and cause a recession that rivaled only the Great Depression in its magnitude.”
Trouble is like many religious prophets of ancient history, they were rejected at the time, cast as dour harbingers of gloom and doom.
Clockwise from upper left: Gary Shilling, Jim Stack, Raghuram Rajan and John Mauldin. Via MarketWatch
Here are four names and their very public warnings that attempted to jolt the financial and banking sectors out of their sleepy stroll toward the abyss before 2008, as well as their predictions for the next big one, and what to look out for.
Howard Gold interviewed each, and laid out the key quotes summarizing then and now…
Economist A. Gary Shilling
President of consultancy A. Gary Shilling & Co., he started writing about a housing bubble in the early 2000s which Greg Lippmann (of “The Big Short” fame), credits with giving him the idea to bet against subprime mortgages. Describes Gold, “he warned his newsletter subscribers about a housing bust and wholesale deleveraging of household debt that would hobble the economy for years.”
And this epic anecdote from the interview:
John Paulson contacted Shilling in August 2006. “He talked about credit default swaps. I didn’t know what they were,” Shilling recalled.
Shilling did some consulting for Paulson’s hedge fund and even invested what “was for the Shillings a major piece of money in this.” Paulson, of course, loaded up on CDS’s and made $4 billion in what has been called “the greatest trade ever.” “We made 15 times our money,” Shilling says.
His predictions pre-2008:
“Subprime loans are probably the greatest financial problem facing the nation in the years ahead.” —January 2004
“The [speculative housing] bubble’s break will cause widespread pain…and be much worse economically than the 2000-2002 bear market.”—June 2006
“We continue to forecast a 25% fall in median single-family house prices nationwide.” —November 2006.
What he says now: 
“The ultimate thing that brings down financial markets is excess leverage … So, you look where’s the big leverage, and right now I think it’s in emerging markets.”
Shilling is particularly worried about the $8 trillion in dollar-denominated emerging-market corporate and sovereign debt, especially as the U.S. dollar rises along with interest rates. “The problem is as the dollar increases,” he said, “it gets tougher and tougher for them to service [that debt] because it takes more and more of their local currency to do so.” Of that, $249 billion must be repaid or refinanced through next year, Bloomberg reported.
* * *
Money manager Jim Stack
President of Stack Financial Management, which manages $1.3 billion, and InvesTech Research, a newsletter he launched in 1979, Jim Stack as a young analyst first gained some notoriety for calling the 1987 stock market crash. Describes Gold, “As housing prices kept rising, Stack built a proprietary tool called the Housing Bellwether Barometer. He called housing a bubble a year before it peaked and warned of bigger problems ahead for the economy and the markets.”
His predictions of a new bear market coming were issued even as stocks were hitting all-time highs.
His predictions pre-2008:
“We are officially calling it a dangerous bubble…I see a trillion+-dollar government bailout of the mortgage industry at some point over the next decade.”—July 2005
“Our Housing Bubble Index has dropped into a freefall that rivals the dot-com bust of the late 1990s… We are moving to a full bear market defensive mode.”—July 2007
“We are nowhere near the bottom…It’s only a matter of time…until the housing debacle and credit crisis adversely impact the overall economy, increasing the likelihood of a recession.”—Interview with Equities magazine, November 2007
What he says now:
That housing-related stocks “saw a parabolic run-up” in 2016-17, but in January his index “peaked and now it’s coming down hard.” And this spells “bad news on the housing market looking 12 months down the road.”
Per Howard Gold’s interview:
But the biggest danger, Stack told me, is from low-quality corporate debt. Issuance of corporate bonds has “gone from around $700 billion in 2008 to about two and a half times that [today].”
And, he added, more and more of that debt is subprime. Uh-oh.
In 2005, he pointed out, companies issued five times as much high-quality as subprime debt, but last year “we had as much subprime debt, poor quality-debt issued, as quality debt on the corporate level,” he said, warning “this is the kind of debt that does get defaulted on dramatically in an economic downturn.”
Banker Raghuram Rajan
Previously the IMF’s chief economist and former head of the Reserve Bank of India, Rajan famously presented a paper at the Federal Reserve Bank of Kansas City’s annual retreat at Jackson Hole, in August 2005. To illustrate the general obsequiousness and self-congratulatory atmosphere of those times, Rajan recalled that some papers at the conference “focused on whether Alan Greenspan was the best central banker in history, or only among the best.”
Per Howard Gold:
Rajan turned out to be a party pooper, questioning whether “advances” in the financial sector actually increased, rather than reduced, systemic risk. Former Treasury Secretary Larry Summers called him a Luddite. “…I felt like an early Christian who had wandered into a convention of half-starved lions,” he wrote. But though delivered in genteel academic lingo, his paper was powerful and prescient.
His predictions pre-2008:
“Managers…have greater incentive to take risk…because the upside is significant, while the downside is limited.”
“Moreover, the linkages between markets, and between markets and institutions, are now more pronounced. While this helps the system diversify across small shocks, it also exposes the system to large systemic shocks…”
“The financial risks that are being created by the system are indeed greater… [potentially creating] a greater (albeit still small) probability of a catastrophic meltdown.”
What he says now:
“There has been a shift of risk from the formal banking system to the shadow financial system.” He also told me the post-crisis reforms did not address central banks’ role in creating asset bubbles through accommodative monetary policy, which he sees as the financial markets’ biggest long-term challenge.
“You get hooked on leverage. It’s cheap, it’s easy to refinance, so why not take more of it? You get lulled into taking more leverage than perhaps you can handle.”
And what might be coming:
Rajan also sees potential problems in U.S. corporate debt, particularly as rates rise, and in emerging markets, though he thinks the current problems in Turkey and Argentina are “not full-blown contagion.”
“But are there accidents waiting to happen? Yes, there are.”
* * *
Writer John Mauldin
Best known for his free weekly e-letter “Thoughts from the Frontline,” the Dallas-based chairman of Mauldin Economics, John Mauldin began worrying about housing very early, sometimes featuring commentary from Gary Shilling during the run-up to the crisis. Described by Gold, he “said a housing bust would lead to a drop in consumer spending, a bear market, and a recession (though at first he thought it would be a mild one), and that credit default swaps (CDSs) posed a systemic risk.”
His predictions pre-2008:
“A slowing of the housing market, and thus the economy, is in our future… This in turn suggests that as growth in consumer spending slows, a bear market in equities is a high-probability outcome.”—March 2006
“…The stock market is going to be under considerable pressure next year. The average drop of the markets is about 40% before and in a recession….Dow 9,000 is a real possibility, if not probability”—December 2006. (The Dow bottomed at 6,547.05 in March 2009.)
“The one true risk that is simply not knowable at this point is in the Credit Default Swap (CDS) market….The CDS market is huge, in the hundreds of trillions of dollars and growing dramatically… There is no agency overseeing counter-party risk. This is the one true systemic risk that I see.”—July 2007.
What he says now:
“I think the choice of Europe is… going to have to put [all the debt] on the balance sheet of the European Central Bank. If they don’t, then the euro zone breaks apart and we’re going to get a 50% valuation collapse.”
“Greece…is a rounding error. Italy is not…. And Brussels and Germany are going to have to allow Italy to overshoot their persistent debt, and the ECB is going to have to buy that debt.”
“If it doesn’t happen, the debt triggers a crisis in Europe, [and] that triggers the beginning of a global recession” but… “there are so many little dominoes, if they all start falling, one leads to the next.”
Comments Howard Gold,
Mauldin estimates the world has almost “half a quadrillion dollars,” or $500 trillion, in debt and unfunded pension and other liabilities, which he views as unsustainable.
But the flashpoint for the next crisis is likely to be in Europe, especially Italy, he maintains.
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Wall Street fantasy NFL game lets users trade athletes like stocks


  • Founded by longtime options traders Eric Wilkinson and Wesley Harr, Draft Hedge offers users a cross between fantasy sports and financial markets.
  • “Whether it’s an e-gaming event or whether it’s football or soccer, or baseball – as long as there’s a quantifiable value, we can create futures around that,” Wilkinson said.
Two traders have developed a futures market to appeal to fantasy sports junkies and Wall Street lifers who want to bet on professional athletes.
Founded by longtime options traders Eric Wilkinson and Wesley Harr, Draft Hedge is a mobile app that offers users a cross between fantasy football and financial markets.
The futures pricing is loosely based on fantasy valuations, with players earning points depending on their performance in each game. Users can buy or sell-short athletes at any time, including the off-season.
“Whether it’s an e-gaming event or whether it’s football or soccer, or baseball – as long as there’s a quantifiable value, we can create futures around that,” Wilkinson told CNBC.
“Analysts are doing the same thing,” he said. “They’re going ‘OK: he’s going to score two touchdowns and 150 yards, and I think this is what his scores are going to be,'” he added. “The overall market probably has a better idea as to what that value is.”
Known as “The Wolfman” around the Chicago Board of Trade, Wilkinson has been trading financial futures, commodities, stocks and options on a variety of products for about 25 years. CNBC viewers may recognize him as the trader who stood next to CNBC’s Rick Santelli during many of his lively appearances from the CME floor.
The CNBC regular also commented on the U.S. Supreme Court’s recent decision to strike down a 1992 federal law that effectively banned commercial sports betting in most states. The ruling sets the stage for the gradual legalization of the millions of dollars of illicit wagers on professional sports Americans make each year.
The trader said that he and Harr were initially worried about the game appearing too much like gambling, and then the court decision came out.
“It was a really big deal for us because we were always thinking that we landed in between financial and betting,” he said. “We were originally worried about our lexicon, whether we ever said betting and things of that nature whereas now we can say whatever we want.”
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FDA keeps warning about kratom, but companies keep deceptively selling it


The U.S. Food and Drug Administration has issued warnings to two additional companies selling the controversial supplement kratom, signaling that the agency’s crackdown on the substance continues to face challenges nearly one year later.
Chillin Mix Kratom, one of the companies, advertises cheap prices and wholesale quantities of the supplement — it sells more than two pounds of powdered kratom for just $65, according to its website — while the other, Mitra Distributing, runs another website selling kratom wholesale.
Both illegally claim that their products can be used as a treatment or cure for opioid addiction and withdrawal symptoms, according to the FDA’s warningletters to them, which were dated Sept. 4 and made public on Tuesday.
Those have been common assertions made about kratom, which comes from an Asian plant and has been made available in pill, powder and other forms.
But the FDA determined earlier this year that kratom shouldn’t be used for any of those conditions, since there’s no evidence that it is safe and effective; the regulator has also concluded that the supplement contains addictive opioids.
The FDA has warned about the product and safety concerns associated with it several times since last fall, including a statement earlier this year that 44 deaths had been associated with the product.

“Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law,” the FDA said in a Tuesday statement. “Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.”
The two companies in question, Chillin Mix Kratom and Mitra Distributing, also claimed that their kratom products could treat conditions like obesity, depression, alcoholism and high blood pressure, according to the FDA.
The U.S. has been in the depths of an opioid epidemic for many years, with opioid overdoses claiming more than 600,000 lives between 1999 and 2016, according to the Centers for Disease Control and Prevention.
Even so, public health experts warn that many barriers, including financial ones, continue to make it difficult to access opioid treatments. There has also been little progress made on developing a better pain medication.

U.S. agencies are working to improve access to FDA-approved treatments for opioid addiction, according to the FDA’s statement, and regulators cannot allow kratom products to prevent affected individuals from getting medication that has been proven to work.
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