FDA Commissioner Resigns Unexpectedly

By Pat Anson, PNN Editor

The head of the U.S. Food and Drug Administration resigned unexpectedly Tuesday, just days after a critical report on 60 Minutes that alleged the FDA “opened the floodgates” to the opioid crisis.  

“I’m immensely grateful for the opportunity to help lead this wonderful agency,” FDA commissioner Scott Gottlieb, MD, tweeted. ”This has been a wonderful journey and parting is very hard.”

In a lengthier statement to FDA staff, Gottlieb cited family reasons for his departure.

“There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children,” Gottlieb said, indicating he would remain on the job until next month.

Gottlieb is a 46-year old cancer survivor and a former consultant to several drug companies. He commutes to Washington DC from his home in Westbury, Connecticut, where he lives with his wife and three daughters.   

President Trump tweeted that Gottlieb “has done an absolutely terrific job” and “he and his talents would be greatly missed!”

SCOTT GOTTLIEB, MD

SCOTT GOTTLIEB, MD

There was no indication that Gottlieb was in trouble or that he was forced out. The FDA is currently involved in a number of complex and controversial regulatory issues, from high drug prices and e-cigarettes to medical marijuana and the opioid crisis.

The timing of Gottlieb’s departure is puzzling, however, because he tweeted two months ago that he had no intention of resigning after hearing from friends about speculation in the news media that he was leaving.

“I want to be very clear — I’m not leaving. We’ve got a lot of important policy we’ll advance this year,” Gottlieb tweeted, adding a famous quote from Mark Twain that reports of his death “have been greatly exaggerated.”

The 60 Minutes report alleged that the FDA caved into lobbying pressure from the pharmaceutical industry in 2001 by changing the warning labels on OxyContin and other opioid medications to indicate they were effective for long term use.

Gottlieb was not working at FDA when the agency made its labeling decision, but pledged last week in a lengthy essay that the FDA would “learn from past mistakes” and take “a much more aggressive approach to regulatory action” involving opioids.

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Gottlieb joins a long list of agency directors and cabinet members who have resigned from the Trump administration, including former Health and Human Services Secretary Tom Price, who was forced out over excessive travel expenses and other ethical lapses, and former CDC director Brenda Fitzgerald, who resigned after it was disclosed she invested in tobacco and drug companies.

FDA Wants More Medical Devices to Treat Pain

By Pat Anson, Editor

The deadline is fast approaching for companies to enter the Food and Drug Administration’s medical device challenge, a contest of sorts aimed at stimulating the development of new technologies to treat pain and prevent opioid abuse.

The FDA announced the innovation program in May and the deadline for applications is September 30.  Medical devices in any state of development – including those already on the market – are eligible for submission.

“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids.”

Devices that are found to innovative will receive a “breakthrough device” designation from the FDA – similar to the “fast track” designation that the agency gives to promising pharmaceutical drugs. With fewer regulatory hurdles, companies can bring their products to the market sooner.

“I think its great. It’s exactly the kind of thing that’s needed,” said Shai Gozani, MD, President and CEO of NeuroMetrix, the maker of Quell. “It’s a little unclear what exactly they’ll offer to the winners. It looks like they’ll give you intensive help for a period of time to climb the regulatory pathway."

In recent years, the FDA has granted or approved over 200 devices related to the treatment and management of pain. One of them was Quell – a nerve stimulation device worn just below the knee – that relieves pain without drugs in patients suffering from arthritis, neuropathy, fibromyalgia and other chronic conditions. Since its release in 2015, over 150,000 Quell devices have been shipped.

This week NeuroMetrix released Quell 2.0 – an updated version that is half the size and weight. Customers wanted a smaller device to make it easier and more comfortable to wear throughout the day and while sleeping.

NEUROMETRIX IMAGE

NEUROMETRIX IMAGE

“The feedback we got from customers over the past three years is that the single most valuable way to improve the product was to make it smaller,” said Gozani.  “Quell 2.0 is half the size, without any sacrifice in the electric stimulation characteristics. In fact, we increased the power by 20 percent, which allows us to stretch the range of patients that can be treated even further.”    

Gozani told PNN there is no single disorder or medical condition that Quell works best on -– it depends more on the individual, who may live with a variety of different conditions.

“Most people who use our product typically have five sites of pain and three or four medical conditions. It’s not like you can say that person has diabetes or that person has lower back pain or knee osteoarthritis. It all overlaps,” he said. “Surprisingly, we’ve seen that it works better in older adults than in younger.”

PNN columnist Jennifer Kilgore, who lives with chronic back pain, has used Quell every day for three years. She appears below in this promotional video for Quell.

A major difference between Quell 2.0 and the older “classic” Quell is that the new version is operated entirely by an app. It adjusts therapy automatically based on body position and doesn’t need to be turned on and off.

Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance. Quell 2.0 sells for $299, while the classic Quell is still available at $249. There’s a 60-day money back guarantee for both.

For more information, click here.

Opioid Prescriptions Plunge to 15-Year Low

By Pat Anson, Editor

The volume of opioid prescriptions in the United States has fallen sharply and now stand at their lowest levels since 2003, according to data released by the Food and Drug Administration.

Over 74 million metric tons of opioid analgesics were dispensed in the first six months of 2018, down more than 16 percent from the first half of 2017. Opioid prescriptions have been declining for several years, but the trend appears to be accelerating as many doctors lower doses, write fewer prescriptions or simply discharge pain patients.

“These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs,” said FDA commissioner Scott Gottlieb, MD, in a statement.

SOURCE: FDA AND IQVIA

SOURCE: FDA AND IQVIA

"This graph confirms the perception that many of use have, that prescribing continues to decline," said Bob Twillman, PhD, Executive Director of Academy of Integrative Pain Management. "But, the question remains --what is the effect of this decreased prescribing on people with chronic pain?

"Measures of prescribing need to be matched with measures of patient function and quality of life, especially given evidence that decreased prescribing may actually be associated with increased suicide. All this measure really tells us is that the intense pressure from legislators, regulators, and payers has had its desired effect of driving down prescribing, even it there’s no evidence that it’s done anything else helpful."

While opioid prescriptions decline, overdoses continue to rise. According to preliminary data from the CDC, nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

“It isn’t necessarily the case that more people are suddenly switching from prescription opioids to these illicit drugs. The idea of people switching to illicit drugs isn’t new as an addiction expands, and some people have a harder time maintaining a supply of prescription drugs from doctors,” said Gottlieb. “What’s new is that more people are now switching to highly potent drugs that are far deadlier. That’s driven largely by the growing availability of the illicit fentanyls.”

Illicit fentanyl and its chemical cousins are synthetic opioids, 50 to 100 times more potent than morphine. They are produced largely by clandestine drug labs in China and then smuggled into the U.S., where they are often mixed with heroin, cocaine and counterfeit drugs.  A record 1,640 pounds of fentanyl and nearly 5,500 pounds of heroin have been seized by law enforcement so far this year; likely a small fraction of what’s available on the black market.

While the Trump administration has expanded efforts to stop the distribution and sale of illicit opioids, it also remains focused on reducing the supply of prescription opioids.  The FDA plans to develop new prescribing guidelines for treating short-term, acute pain that will likely set a cap on the number of pills that can be prescribed for certain medical conditions.

No more 30-day prescriptions for a tooth extraction or an appendectomy,” said Gottlieb.

The Justice Department also recently announced plans to lower production quotas by 10% next year for six widely prescribed opioid medications. The goal of the administration is to reduce opioid prescriptions by a third in the next three years. 

“The number of opioid prescriptions is only one of many factors and may not be the most important factor contributing to the opioid crisis. In fact, the U.S. is at a 15-year low in the amount of opioid prescribed but continues to see a surge of drug overdoses,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.

“Much of the effort to curb the amount of prescription opioids has contributed to more suffering by people in chronic pain and possibly the increase in suicides.  It also hasn't done anything to curb the number of overdose deaths. Rather than being focused on number of pills or amount of opioid prescribed we need to focus on what is the best and most appropriate treatment for individual patients. When that is done properly, the right amount of opioids will be prescribed.”  

FDA to Develop Acute Pain Guidelines

By Pat Anson, Editor

The head of the U.S. Food and Drug Administration is following up on a promise to develop new federal prescribing guidelines for treating short-term, acute pain. But don't expect an overhaul of the CDC's controversial opioid guideline.

FDA commissioner Scott Gottlieb, MD, announced today that his agency has awarded a contract  to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop guidelines for prescribing opioids for acute pain that results from specific medical conditions or procedures, such as wisdom tooth removal or post-operative pain.  

The CDC guideline takes a one-size-fits-all approach to chronic pain -- pain that lasts longer than three months -- and doesn't distinguish between pain from fibromyalgia, arthritis, neuropathy or any other medical condition.  

"We’ve contracted with NASEM to conduct a consensus study and issue a report on its findings. This work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices," Gottlieb said in a statement.

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"We acknowledge the work of our colleagues at the U.S. Centers for Disease Control and Prevention (CDC) who have taken an initial step in developing federal guidelines on pain management and the use of opioids which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed. The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific." 

Importantly, Gottlieb says NASEM will hold a series of public meetings and workshops, and seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

While Gottlieb clearly wants more transparency brought to the guideline development process, he also clings to the notion that opioid medication is overprescribed and is primarily responsible for the nation's opioid crisis.

"Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids," Gottlieb said.

"Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills – maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed. In some cases, the excess pills that aren’t used by patients may end up being diverted to illicit markets or misused or abused by friends or family members. In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse and addiction."

But studies show that long-term opioid use by patients recovering from surgery is rare and less than one percent of legally prescribed opioids are diverted.

In 2016, the American Pain Society released guidelines that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain. Among the treatments suggested are pregabalin, gabapentin, NSAIDs and acetaminophen.

The University of Michigan has also developed prescribing guidelines for over a dozen common surgeries, ranging from hernia repair to hysterectomies. The recommendations list the suggested dose of opioids and number of pills for each procedure.      

Several states have already adopted their own guidelines for acute pain, limiting opioids to a few days' supply -- regardless of whether the pain is from a broken leg, a tonsillectomy or gunshot wound.  It's not clear how federal guidelines for acute pain would impact state regulations.

FDA Warns Veterinarians of Pet Owners Abusing Opioids

By Pat Anson, Editor

Doctors and patients aren’t the only ones under scrutiny for prescribing and using opioid pain medication. Pet owners are also coming under suspicion for diverting and abusing opioids intended for their animals.

The Food and Drug Administration today warned veterinarians to be cautious when prescribing opioids and be on the alert for people who may be using their pets to gain access to the drugs.

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“We recognize that opioids and other pain medications have a legitimate and important role in treating pain in animals – just as they do for people,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“But just like the opioid medications used in humans, these drugs have potentially serious risks, not just for the animal patients, but also because of their potential to lead to addiction, abuse and overdose in humans who may divert them for their own use.”

Only one opioid is currently approved by the FDA for use in animals, a potent fentanyl medication for post-surgical pain that is sold under the brand name Recuvyra.  

The maker of another fentanyl based product -- carfentanil -- voluntarily surrendered approval for the drug in March because of growing signs it was being diverted. Carfentanil is so potent it was used by veterinarians as an anesthetic on elephants.   

With few options to choose from, some veterinarians are legally prescribing tramadol and others opioids intended for humans to relieve pain in pets. The FDA is recommending veterinarians use alternatives to opioids whenever possible and look for signs of opioid abuse by pet owners and their own employees.

“We’re advising veterinarians to develop a safety plan in the event they encounter a situation involving opioid diversion or clients seeking opioids under the guise of treating their pets; and taking steps to help veterinarians spot the signs of opioid abuse,” Gottlieb said.

Possible warning signs of opioid abuse are suspicious injuries to animals, a pet owner asking for specific medication by name, or asking for refills of lost or stolen medication.

Gottlieb’s statement was released one week after a small study published in the American Journal of Public Health suggested that some pet owners are purposely injuring their animals to gain access to opioids.

"Our results indicate that we should be paying more attention to how opioid abusers are seeking their drugs -- including through veterinary clinics," said Lili Tenney, deputy director of the Center for Health, Work & Environment at the Colorado School of Public Health.

In a survey of 189 Colorado veterinarians, 13 percent reported they had seen a client who they believed had purposefully injured a pet or made them ill. Nearly half the vets said they knew of a pet owner or employee who was abusing opioids; and 12 percent suspected a staff member of diverting opioids or abusing them.

Colorado and Maine require veterinarians to look at a pet owner’s medication history before dispensing opioids or writing a prescription.  Over a dozen states require veterinarians to report when they prescribe opioids to a prescription drug database.

FDA Monitors Social Media for Drug Abuse Trends

By Pat Anson, Editor

A recent letter in The New England Journal of Medicine sheds some light on how the Food and Drug Administration tracks changing patterns of drug use on Facebook, Twitter and other social media.

The FDA began monitoring social media – what it calls “proactive pharmacovigilance” – about a decade ago, primarily as an early warning system for adverse events involving medication.

More recently, the agency has used active surveillance of social media to study the abuse of opioid painkillers and gabapentinoids, a class of nerve medication that includes gabapentin (Neurontin) and pregabalin (Lyrica). Gabapentinoids are increasingly being prescribed as “safer” alternatives to opioids.

“To understand why usage patterns are shifting, the FDA used a social media ‘listening platform’ to set up a dashboard to track traditional social media sites (such as Twitter, Facebook, Instagram, blogs, and forums) that we monitor for conversations about opioids,” explained FDA commissioner Scott Gottlieb, MD, and co-authors Douglas Throckmorton, MD, and Janet Woodcock, MD, two senior FDA officials.

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“When we find mention of additional substances on social media or elsewhere, we conduct more specific searches for relevant, publicly available conversations through our listening platform, as well as through Reddit, Google, and various online forums that don’t require registration or subscription. These may include forums associated with drug misuse or abuse, such as Bluelight.org and talk.drugabuse.com.”

What did the FDA learn about gabapentinoids on social media? Preliminary findings indicate the abuse of gabapentinoids isn’t widespread, but their use continues to increase, especially for gabapentin.

The FDA is also actively monitoring the social media sites of kratom vendors. As PNN reported last month, one vendor received a warning letter from the FDA for sharing on its Facebook page a CNN story about the herbal supplement as a possible treatment for pain and opioid addiction. The vendor only said the story was “positive news for kratom,” but the FDA said that amounted to the illegal marketing of an unapproved drug.

“The FDA thus faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” Gottlieb wrote. “The right approach to regulating these substances is best determined through a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used.”

To be clear, the FDA’s surveillance of social media isn’t very different from what private enterprise is already doing. NUVI, for example, provide social media monitoring to companies “to get real-time insights into what people are saying about your brand online.”  Companies also sell software that track keywords, hashtags and user profiles on social media. And PatientsLikeMe, the largest online patient network with over 600,000 members, sells some of its data to the FDA and healthcare industry.

At PNN, we do stories all the time about opioids, kratom, gabapentinoids and other drugs. Is Pain News Network under surveillance by the FDA? Are reader comments on our website and social media being monitored? We don’t know. But in an age of growing concern about Internet privacy and the sharing of personal data, we thought you should know that the answer could be yes.

FDA Uncovers Errors in Opioid Database

By Pat Anson, Editor

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA - a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. "The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year."

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

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Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two prominent healthcare research firms. The company released a statement saying it identified the problems in its opioid database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

If confirmed, the database errors would be the second admission by federal agencies this year that their analysis of opioid prescriptions relied on faulty data. In March, four researchers in the CDC’s ironically named Division of Unintentional Injury Prevention acknowledged that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths.

FDA Commissioner Listening to Chronic Pain Patients

By Pat Anson, Editor

Chronic pain sufferers have long complained that they rarely get a seat at the table when important decisions are being made about opioid medication.

Last year President Trump’s opioid commission held five public hearings without ever inviting a patient, patient advocate or pain management physician to testify.  The Centers for Disease Control and Prevention also ignored the pain community in 2015 when it secretly drafted its opioid prescribing guideline, relying instead on the advice of addiction treatment specialists and anti-opioid activists.

Now there is a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S.

The Food and Drug Administration is seeking comments from patients only on the challenges they face finding treatment and on the effectiveness of opioids and other types of pain medication. Patients are invited to submit their comments by mail or in the Federal Register, and to attend a public meeting on July 9. Click here for more details.

The meeting is the latest in a series of step ordered by FDA Commissioner Scott Gottlieb, MD, to get more public input on how to deal with the opioid crisis.  In January, dozens of pain patients and their advocates expressed their concerns to the FDA’s Opioid Policy Steering Committee.

“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote in an online blog.

“We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients. This might include patients with metastatic cancer or severe adhesive arachnoiditis.”

SCOTT GOTTLIEB, MD

SCOTT GOTTLIEB, MD

Gottlieb also signaled that the FDA is considering the development of prescribing guidelines for specific chronic pain conditions – not the one-size-fits-all approach taken by the CDC.

“We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs,” he wrote.

“In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.”

Although Gottlieb has angered some in the pain community with his crackdowns on kratom and stem cell clinics, he does appear to have a sympathetic ear for pain sufferers. In 2012, a full five years before becoming FDA commissioner, Gottlieb warned that heavy-handed enforcement actions by the DEA were interfering with patient care.  

“This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need,” Gottlieb wrote in a prophetic column published in The Wall Street Journal.

To leave a public comment for the FDA in the Federal Register, click here. Comments will be accepted until September 10, 2018.

FDA Seeks Shutdown of Stem Cell Clinics

By Pat Anson Editor

The U.S. Food and Drug Administration has stepped up its crackdown on the stem cell industry by filing two complaints in federal court seeking permanent injunctions against stem cell clinics in Florida and California.

US Stem Cell of Sunrise, Florida and California Stem Cell Treatment Center are accused of marketing stem cell products without FDA approval and for “significant deviations” from safety and manufacturing guidelines. Both companies said they would “vigorously defend” themselves and challenge the FDA’s authority to regulate autologous stem cells, which are made from a patient’s own blood or tissue.

The  lawsuits could ultimately decide the fate of hundreds of stem cell clinics that have opened around the country in recent years, offering new therapies for arthritis, neuropathy, degenerative disc disease and other chronic conditions.

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

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In 2015, three elderly women became legally blind after having unapproved stem cell treatments for macular degeneration at US Stem Cell. The clinic was also warned by the FDA last year to stop using adipose tissue (body fat) to make stem cells that were injected into the spinal cords of patients.

The FDA alleges that California Stem Cell Treatment Center – which has clinics in Beverly Hills and Rancho Mirage -- is also using stem cells derived from adipose tissue to treat patients suffering from arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), diabetes, cancer and other conditions.

“The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors,” the FDA said.

The case against California Stem Cell could have a broad impact because it also targets the Cell Surgical Network Corporation (CSN), which has a chain of about 100 stem cell clinics. At issue in both lawsuits is whether a patient’s own stem cells can be used for therapeutic purposes and are outside the control of federal agencies like the FDA.

“CSN strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug,” Dr. Elliot Lander of CSN and California Stem Cell Treatment Center said in an email to The Niche, a stem cell blog.

“We share FDA’s concern for patient safety, but do not believe that FDA regulation of a surgical procedure that simply harnesses the healing power of a patient’s own cells, without altering the biological characteristics of those cells, is the answer. The decision of whether or not the surgical procedure is performed should be made by the patient and physician – not the FDA or any other arm of the federal government.”

US Stem Cell also released a statement on its website, saying it would “vigorously defend medical freedom of Americans.”

FDA Orders Recall of Kratom Linked to Salmonella Scare

By Pat Anson, Editor

The U.S. Food and Drug Administration has issued a mandatory recall for kratom capsules made by a Las Vegas company after several of its products were found to be contaminated with salmonella bacteria.

The FDA said it ordered the recall after Triangle Pharmanaturals failed to cooperate with the agency’s request to conduct a voluntary recall.

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The FDA is advising consumers to discard kratom products made by Triangle, which include Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The products are sold in 300 capsule plastic bottles.

It’s possible other brands may be included in the recall because Triangle manufactures and packages kratom products for other companies.

“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

“We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”

The FDA said Triangle did not cooperate with its investigation or order a voluntary recall after six samples of its kratom products tested positive for salmonella. “FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings,” the FDA said.

The company did not immediately respond to a request for comment.

At least 87 people have been sickened in 35 states by a salmonella outbreak linked to kratom – an herbal supplement used by millions of Americans to treat chronic pain, depression, anxiety and addiction. At least one other kratom distributor – PDX Aromatics of Portland, Oregon – agreed to voluntarily recall its products after several were found contaminated with salmonella.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in hospitalization or even death.

Kratom is usually sold in powder, capsules or leaves.  The Centers for Disease Control and Prevention has not been able to trace the salmonella outbreak to a single brand or source, so it is recommending that people not consume “any brand of kratom in any form.”

The FDA has also warned against consuming kratom, claiming it has opioid-like qualities and could lead to addiction. In recent months, the FDA has released a public health advisory warning that kratom should not be marketed as a treatment for any medical condition. The agency also released a computer analysis that found kratom contains over two dozen opioid-like substances.

Under the Food Safety Modernization Act, the FDA has broad authority to order the recall of food products when the agency determines that there is a reasonable probability the food is adulterated or could have serious health consequences.