FDA Approves Stem Cell Study for Degenerative Disc Disease

By Pat Anson

The Food and Drug Administration has given the go-ahead for a late-stage clinical trial of an injectable stem cell product that could give new hope to millions of patients suffering from lower back pain caused by degenerative disc disease (DDD).  Up to 400 patients with mild to moderate DDD are expected to enroll in the Phase 3 study later this year.

The trial is being conducted by DiscGenics, a Utah-based biopharmaceutical company that is developing new cell-based therapies for musculoskeletal conditions. It’s one of the first late-stage studies of a stem cell product to win approval from the FDA, which has been openly skeptical of cell-based therapies due to lack of evidence proving their safety and efficacy in clinical trials.

The only stem cell therapies currently approved by the FDA are used to treat sickle cell disease and some cancers. Approval of a stem cell product to treat degenerative discs would be a big step forward for regenerative medicine, and give patients an alternative to fusions and other more invasive spinal procedures.

“The FDA has been very familiar with our process, our product, and the chemistry, manufacturing and controls for quite some time,” says Flagg Flanagan, CEO and Chairman of DiscGenics. “We feel really good about where we are in terms of the patient reported outcomes. But most importantly about the safety. We feel like this cell is extremely safe to be used on human patients and we're feeling really, really good that we can help a lot of people.”

Discgenics’ injectable disc cell therapy (IDCT) is a single-injection biologic treatment designed to halt the progression of lumbar DDD by regenerating the disc “from the inside out.” The active ingredients in IDCT are enriched stem cells known as discogenic cells, which are derived from donated adult human disc tissue.

IDCT has been granted regenerative medicine advanced therapy and Fast Track designations by the FDA. Approval of the Phase 3 study came just weeks after Discgenics released positive results from a combined Phase 1/Phase 2 human trial of IDCT, published in the International Journal of Spine Surgery.

In that study, 60 patients with mild to moderate DDD were randomly assigned to receive an injection of either low-dose discogenic cells, high-dose cells, or a placebo. After one year, patients in the high-dose group had an average reduction in pain intensity of nearly 63 percent, along with significant improvements in their disability and quality of life. The regeneration of discs, which was monitored through MRIs and other imaging tests, was sustained two years after the injection.

“Things even came out a little better than we even expected,” Flanagan told PNN. “We showed very good durability, out to two years with the high dose patients. Anecdotally, we continue to follow some of those high dose patients and we have data in a pretty good cohort out to three years. We have a couple (patients) out to four years and the durability still seems to hold pretty well.”

The Phase 3 trial will consist of two parallel studies of IDCT that will also be randomized and placebo-controlled. Like the two earlier trials, each study will last for two years to assess the long-term safety and efficacy of IDCT. The first participants are expected to be enrolled in the final quarter of 2024.

“We'll start looking for patients and reviewing patient profiles that want to apply for the study shortly,” Flanagan said. “I think this is something where we can help many, many patients hopefully avoid a surgical intervention with an injection in a treatment room.”

People interested in getting updates on the Phase 3 IDCT trial or volunteering for it can submit their contact information to DiscGenics here.

Mesoblast, an Australian company specializing in regenerative medicine, recently began enrolling U.S. patients with chronic low back pain in a Phase 3 study of its proprietary mesenchymal stem cells, which are derived from young and healthy adult donors.

Feds Warn About Copycat Packaging of Delta-8 THC Edibles

By Crystal Lindell

The U.S. government is once again going after companies that sell Delta-8 THC edibles in packaging that looks like popular brand name candy and snacks. 

The Food and Drug Administration and the Federal Trade Commission sent warning letters to five companies for selling copycat food products containing delta-8 THC derived from hemp.

For example, one company was selling a package of “Slizzles” edibles that looks strikingly similar to “Skittles” candy. Another company sold a “Double Stuff Stoneo” product in packaging that looks like “Oreo” cookies. 

The cease and desist warning letters were issued to Hippy Mood, Earthly Hemps, Shamrockshrooms, Mary Janes Bakery and Life Leaf Medical CBD Center. 

“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” FDA Principal Deputy Commissioner Namandjé Bumpus, PhD, said in a statement. 

“As accidental ingestion and/or overconsumption of Delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.”

Delta-8 THC is derived from hemp, which Congress legalized in the 2018 Farm Bill. Hemp contains only trace amounts of THC, the psychoactive ingredient in cannabis, so the thinking was that hemp would only be used to make cash products such as rope, clothing and horse feed. It didn’t take long, however, for cannabis companies to develop a synthetic form of hemp-derived THC that is just as potent as regular THC. 

Efforts are underway to close that loophole in the next Farm Bill, but in the meantime delta-8 THC products remain legal under federal law, although some individual states have banned them. 

In 2022 and 2023, the feds issued similar warnings against other companies marketing Delta-8 THC edibles. Although those products were withdrawn from the market, other companies have stepped into the void and began selling similar ones. 

The FDA and FTC say the copycat branding of delta-8 edibles violates federal laws against unfair or deceptive marketing, including practices that present health or safety risks. The agencies say children are particularly vulnerable, because they might not realize the edibles contain THC. 

“Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk,” said Samuel Levine, director of the FTC’s Bureau of Consumer Protection. “Those that prioritize profits in front of children's safety are at serious risk of legal action.”

Industry groups that represent companies that have seen their branded products mimicked have come out against this type of copycat packaging.  The Consumer Brands Association (CBA) has a position paper on its website specifically addressing THC edibles that mimic popular brands. 

“Companies are unequivocally opposed to their brands being illegally used in products containing THC,” the CBA writes. “But rooting out these bad actors is like a game of whack-a-mole. By the time a company or government entity goes after them, their local storefront or online presence disappears and they pop up with a new name and new site.”

The issue goes beyond simple copyright infringement. The CBA cites recent data showing that national poison control centers handled nearly 10,500 incidents involving products laced with THC. Of those cases, 77% involved consumers 19 years old or younger.

“The urgency of this issue is not about intellectual property infringement, but about how that infringing use of trusted food brands creates a direct threat to consumer safety — particularly that of children,” the CBA says. “As incidents of children being hurt by lookalike products that endanger them increase, greater enforcement is necessary.”

The National Confectioners Association (NCA) has also warned about cannabis companies using packages that looks like popular candy and snacks.

Edibles may deliberately mimic the trade dress of beloved consumer brands,” the NCA said. “It is often very difficult to distinguish these edibles from conventional foods and beverages, resulting in confusion and injury to consumers, including children, and reputational damage to food companies.”

The NCA says it is difficult and costly for companies to try to protect their brands in this situation, because it requires “state-by-state surveillance” and “burdensome legal action.”

The FDA is also concerned about the processes used to synthesize delta-8 THC, as impurities or variations in the processing can result in products that may be harmful or have unpredictable effects. The agency has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. 

FDA and CDC Face Flood of Litigation After Supreme Court Ruling

By Stephanie Armour, KFF Health News

A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care.

The June 28 decision overturns a 1984 precedent that said courts should give deference to federal agencies in legal challenges over their regulatory or scientific decisions. Instead of giving priority to agencies, courts will now exercise their own independent judgment about what Congress intended when drafting a particular law.

The ruling will likely have seismic ramifications for health policy. A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations they say aren’t specified in the law — could leave the country with a patchwork of disparate health regulations varying by location.

Agencies such as the FDA are likely to be far more cautious in drafting regulations, Congress is expected to take more time fleshing out legislation to avoid legal challenges, and judges will be more apt to overrule current and future regulations.

Health policy leaders say patients, providers, and health systems should brace for more uncertainty and less stability in the health care system. Even routine government functions such as deciding the rate to pay doctors for treating Medicare beneficiaries could become embroiled in long legal battles that disrupt patient care or strain providers to adapt.

Groups that oppose a regulation could search for and secure partisan judges to roll back agency decision-making, said Andrew Twinamatsiko, director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute. One example could be challenges to the FDA’s approval of a medication used in abortions, which survived a Supreme Court challenge this term on a technicality.

“Judges will be more emboldened to second-guess agencies,” he said. “It’s going to open agencies up to attacks.”

Regulations are effectively the technical instructions for laws written by Congress. Federal agency staffers with knowledge related to a law — say, in drugs that treat rare diseases or health care for seniors — decide how to translate Congress’ words into action with input from industry, advocates, and the public.

Fragmented Health Policy

Up until now, when agencies issued a regulation, a single rule typically applied nationwide. Following the high court ruling, however, lawsuits filed in more than one jurisdiction could result in contradictory rulings and regulatory requirements — meaning health care policies for patients, providers, or insurers could differ greatly from one area to another.

One circuit may uphold a regulation from the Centers for Disease Control and Prevention, for example, while other circuits may take different views.

“You could have eight or nine of 11 different views of the courts,” said William Buzbee, a professor at Georgetown Law.

A court in one circuit could issue a nationwide injunction to enforce its interpretation while another circuit disagrees, said Maura Monaghan, a partner at Debevoise & Plimpton. Few cases are taken up by the U.S. Supreme Court, which could leave clashing directives in place for many years.

In the immediate future, health policy leaders say agencies should brace for more litigation over controversial initiatives. A requirement that most Affordable Care Act health plans cover preventive services, for example, is already being litigated. Multiple challenges to the mandate could mean different coverage requirements for preventive care depending on where a consumer lives.

Drugmakers have sued to try to stop the Biden administration from implementing a federal law that forces makers of the most expensive drugs to negotiate prices with Medicare — a key cog in President Joe Biden’s effort to lower drug prices and control health care costs.

Parts of the health care industry may take on reimbursement rates for doctors that are set by the Centers for Medicare & Medicaid Services because those specific rates aren’t written into law. The agency issues rules updating payment rates in Medicare, a health insurance program for people 65 or older and younger people with disabilities. Groups representing doctors and hospitals regularly flock to Washington, D.C., to lobby against trims to their payment rates.

And providers, including those backed by deep-pocketed investors, have sued to block federal surprise-billing legislation. The No Surprises Act, which passed in 2020 and took effect for most people in 2022, aims to protect patients from unexpected, out-of-network medical bills, especially in emergencies. The high court’s ruling is expected to spur more litigation over its implementation.

“This really is going to create a tectonic change in the administrative regulatory landscape,” Twinamatsiko said. “The approach since 1984 has created stability. When the FDA or CDC adopt regulations, they know those regulations will be respected. That has been taken back.”

Industry groups, including the American Hospital Association and AHIP, an insurers’ trade group, declined to comment.

Agencies such as the FDA that take advantage of their regulatory authority to make specific decisions, such as the granting of exclusive marketing rights upon approval of a drug, will be vulnerable. The reason: Many of their decisions require discretion as opposed to being explicitly defined by federal law, said Joseph Ross, a professor of medicine and public health at Yale School of Medicine.

“The legislation that guides much of the work in the health space, such as FDA and CMS, is not prescriptive,” he said.

In fact, FDA Commissioner Robert Califf said in an episode of the “Healthcare Unfiltered” podcast last year that he was “very worried” about the disruption from judges overruling his agency’s scientific decisions.

The high court’s ruling will be especially significant for the nation’s federal health agencies because their regulations are often complex, creating the opportunity for more pitched legal battles.

Challenges that may not have succeeded in courts because of the deference to agencies could now find more favorable outcomes.

“A whole host of existing regulations could be vulnerable,” said Larry Levitt, executive vice president for health policy at KFF.

Other consequences are possible. Congress may attempt to flesh out more details when drafting legislation to avoid challenges — an approach that may increase partisan standoffs and slow down an already glacial pace in passing legislation, Levitt said.

Agencies are expected to be far more cautious in writing regulations to be sure they don’t go beyond the contours of the law.

The Supreme Court’s 6-3 decision overturned Chevron U.S.A. v. Natural Resources Defense Council, which held that courts should generally back a federal agency’s statutory interpretation as long as it was reasonable. Republicans have largely praised the new ruling as necessary for ensuring agencies don’t overstep their authority, while Democrats said in the aftermath of the decision that it amounts to a judicial power grab.

KFF Health News is a national newsroom that produces in-depth journalism about health issues. 

‘We’re Flying Blind’: Response to Bird Flu Outbreak Mirrors Covid Errors

By Amy Maxmen, KFF Health News

It’s been nearly three months since the U.S. government announced an outbreak of the bird flu virus on dairy farms. The World Health Organization considers the virus a public health concern because of its potential to cause a pandemic, yet the U.S. has tested only about 45 people across the country.

“We’re flying blind,” said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. With so few tests run, she said, it’s impossible to know how many farmworkers have been infected, or how serious the disease is. A lack of testing means the country might not notice if the virus begins to spread between people — the gateway to another pandemic.

“We’d like to be doing more testing. There’s no doubt about that,” said Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention. The CDC’s bird flu test is the only one the Food and Drug Administration has authorized for use right now. Shah said the agency has distributed these tests to about 100 public health labs in states.

“We’ve got roughly a million available now,” he said, “and expect 1.2 million more in the next two months.”

But Nuzzo and other researchers are concerned because the CDC and public health labs aren’t generally where doctors order tests from. That job tends to be done by major clinical laboratories run by companies and universities, which lack authorization for bird flu testing.

As the outbreak grows — with at least 114 herds infected in 12 states as of June 18 — researchers said the CDC and FDA are not moving fast enough to remove barriers that block clinical labs from testing. In one case, the diagnostics company Neelyx Labs was on hold with a query for more than a month.

“Clinical labs are part of the nation’s public health system,” said Alex Greninger, assistant director of the University of Washington Medicine Clinical Virology Laboratory. “Pull us into the game. We’re stuck on the bench.”

The CDC recognized the need for clinical labs in a June 10 memo. It calls on industry to develop tests for the H5 strain of bird flu virus, the one circulating among dairy cattle.

“The limited availability and accessibility of diagnostic tests for Influenza A(H5) poses several pain points,” the CDC wrote. The points include a shortage of tests if demand spikes.

Testing Failures Made Pandemic Worse

Researchers, including former CDC director Tom Frieden and Anthony Fauci, who led the nation’s response to covid, cite testing failures as a key reason the U.S. fared so poorly with covid. Had covid tests been widely available in early 2020, they say, the U.S. could have detected many cases before they turned into outbreaks that prompted business shutdowns and cost lives.

In an article published this month, Nuzzo and a group of colleagues noted that the problem wasn’t testing capability but a failure to deploy that capability swiftly. The U.S. reported excess mortality eight times as high as other countries with advanced labs and other technological advantages.

A covid test vetted by the WHO was available by mid-January 2020. Rather than use it, the United States stuck to its own multistage process, which took several months. Namely, the CDC develops its own test then sends it to local public health labs. Eventually, the FDA authorizes tests from clinical diagnostic labs that serve hospital systems, which must then scale up their operations. That took time, and people died amid outbreaks at nursing homes and prisons, waiting on test results.

In contrast, South Korea immediately rolled out testing through private sector laboratories, allowing it to keep schools and businesses open. “They said, ‘Gear up, guys; we’re going to need a ton of tests,’” said Frieden, now president of the public health organization Resolve to Save Lives. “You need to get commercials in the game.” 

Nuzzo and her colleagues describe a step-by-step strategy for rolling out testing in health emergencies, in response to mistakes made obvious by covid. But in this bird flu outbreak, the U.S. is weeks behind that playbook.

Ample testing is critical for two reasons. First, people need to know if they’re infected so that they can be quickly treated, Nuzzo said. Over the past two decades, roughly half of about 900 people around the globe known to have gotten the bird flu died from it.

Although the three farmworkers diagnosed with the disease this year in the United States had only mild symptoms, like a runny nose and inflamed eyes, others may not be so lucky. The flu treatment Tamiflu works only when given soon after symptoms start.

The CDC and local health departments have tried to boost bird flu testing among farmworkers, asking them to be tested if they feel sick. Farmworker advocates list several reasons why their outreach efforts are failing. The outreach might not be in the languages the farmworkers speak, for example, or address such concerns as a loss of employment.

If people who live and work around farms simply see a doctor when they or their children fall ill, those cases could be missed if the doctors send samples to their usual clinical laboratories. The CDC has asked doctors to send samples from people with flu symptoms who have exposure to livestock or poultry to public health labs.

“If you work on a farm with an outbreak and you’re worried about your welfare, you can get tested,” Shah said.

But sending samples to public health departments requires knowledge, time, and effort.

“I really worry about a testing scheme in which busy clinicians need to figure this out,” Nuzzo said.

‘Get Prepared Before Things Get Crazy’

The other reason to involve clinical laboratories is so the nation can ramp up testing if the bird flu is suddenly detected among people who didn’t catch it from cattle. There’s no evidence the virus has started to spread among people, but that could change in coming months as it evolves.

The fastest way to get clinical labs involved, Greninger said, is to allow them to use a test the FDA has already authorized: the CDC’s bird flu test. On April 16 the CDC opened up that possibility by offering royalty-free licenses for components of its bird flu tests to accredited labs.

Several commercial labs asked for licenses. “We want to get prepared before things get crazy,” said Shyam Saladi, chief executive officer of the diagnostics company Neelyx Labs, which offered covid and mpox tests during shortages in those outbreaks. His experience over the past two months reveals the types of barriers that prevent labs from moving swiftly.

In email exchanges with the CDC, shared with KFF Health News, Saladi specifies the labs’ desire for licenses relevant to the CDC’s test, as well as a “right to reference” the CDC’s data in its application for FDA authorization.

That “right to reference” makes it easier for one company to use a test developed by another. It allows the new group to skip certain analyses conducted by the original maker, by telling the FDA to look at data in the original FDA application. This was commonplace with covid tests at the peak of the pandemic.

At first, the CDC appeared eager to cooperate. “A right of reference to the data should be available,” Jonathan Motley, a patent specialist at the CDC, wrote in an email to Saladi on April 24. Over the next few weeks, the CDC sent him information about transferring its licenses to the company, and about the test, which prompted Neelyx’s researchers to buy testing components and try out the CDC’s process on their equipment.

But Saladi grew increasingly anxious about the ability to reference the CDC’s data in the company’s FDA application. “Do you have an update with respect to the right of reference?” he asked the CDC on May 13. “If there are any potential sticking points with respect to this, would you mind letting us know please?”

He asked several more times in the following weeks, as the number of herds infected with the bird flu ticked upward and more cases among farmworkers were announced. “Given that it is May 24 and the outbreak has only expanded, can CDC provide a date by which it plans to respond?” Saladi wrote.

The CDC eventually signed a licensing agreement with Neelyx but informed Saladi that it would not, in fact, provide the reference. Without that, Saladi said, he could not move forward with the CDC’s test — at least not without more material from the agency. “It’s really frustrating,” he said. “We thought they really intended to support the development of these tests in case they are needed.”

Shah, from the CDC, said test manufacturers should generate their own data to prove that they’re using the CDC’s test correctly. “We don’t have a shortage such that we need to cut corners,” he said. “Quality reigns supreme.”

The CDC has given seven companies, including Neelyx, licenses for its tests — although none have been cleared to use them by the FDA. Only one of those companies asked for the right of reference, Shah said. The labs may be assisted by additional material that the agency is developing now, to allow them to complete the analyses — even without the reference.

“This should have happened sooner,” Saladi told KFF Health News when he was told about the CDC’s pending additional material. “There’s been no communication about this.”

Greninger said the delays and confusion are reminiscent of the early months of covid, when federal agencies prioritized caution over speed. Test accuracy is important, he said, but excessive vetting can cause harm in a fast-moving outbreak like this one. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he said. “I fall on the side of allowing labs to get ready — that’s a no-brainer.”

Clinical laboratories have also begun to develop their own tests from scratch. But researchers said they’re moving cautiously because of a recent FDA rule that gives the agency more oversight of lab-developed tests, lengthening the pathway to approval. In an email to KFF Health News, FDA press officer Janell Goodwin said the rule’s enforcement will occur gradually.

However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the nation’s largest commercial diagnostic labs, said companies need more clarity: “It’s slowing things down because it’s adding to the confusion about what is allowable.”

Creating tests for the bird flu is already a risky bet, because demand is uncertain. It’s not clear whether this outbreak in cattle will trigger an epidemic or fizzle out. In addition to issues with the CDC and FDA, clinical laboratories are trying to figure out whether health insurers or the government will pay for bird flu tests.

These wrinkles will be smoothed eventually. Until then, the vanishingly slim numbers of people tested, along with the lack of testing in cattle, may draw criticism from other parts of the world.

“Think about our judgment of China’s transparency at the start of covid,” Nuzzo said. “The current situation undermines America’s standing in the world.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.  

Public Comments Sought on Marijuana Rescheduling

By Pat Anson, PNN Editor

The U.S. public is finally getting a chance to comment on the federal government’s historic decision to reclassify marijuana from a Schedule I substance with a “high potential for abuse” to a less restrictive Schedule III drug with “moderate to low potential for physical and psychological dependence.”

After months of foot dragging, the Justice Department published a notice in the Federal Register today giving the public 60 days to comment on the proposed rescheduling. Written comments must be submitted or postmarked on or before July 22. Online comments can be made here.

Every step in this process has been fraught with delays. And there may be more.

The Food and Drug Administration completed a review last August – nearly a year after it was requested by President Biden -- finding “credible scientific support” for marijuana’s rescheduling. But the FDA report was not made public until January, after a lawsuit was filed by two pro-cannabis lawyers seeking its release when the agency didn’t respond to requests under the Freedom of Information Act (FOIA).

Another four months passed before the Justice Department, which oversees the Drug Enforcement Administration, submitted to the Federal Register a notice about the proposed rescheduling. Since the DEA is charged with enforcing the Controlled Substances Act (CSA) and determines how drugs are scheduled, public notices involving the CSA are almost always signed by the DEA administrator.

This one, however, is signed by Attorney General Merrick Garland, not DEA Administrator Anne Milgram – a sign that her agency is not yet on board with marijuana’s rescheduling.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” Garland wrote. “The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs… The Attorney General has delegated that authority to the DEA Administrator, but also retains the authority to schedule drugs under the CSA in the first instance.”

According to an Associated Press report, Milgram told her staff in March that marijuana’s rescheduling “had been taken over” by Garland and the DOJ. The DEA wanted more time for studies to determine whether marijuana has an accepted medical use, a request that was rejected.

Former DEA Administrator Tim Shea believes the rescheduling process was hijacked by DOJ for political reasons.

“If she (Milgram) had supported it she would have signed it and sent it in,” Shea told the AP. “DEA was opposed to this and the politics entered and overruled them. It’s demoralizing. Everybody from the agents in the streets to the leadership in DEA knows the dangers this brings.”   

Asked recently during a congressional hearing what her views are on marijuana. Milgram ducked the question.

“Since DEA is ultimately the decider of scheduling and rescheduling, and the DEA administrator is in that role, it would be inappropriate for me to make comments about this process or parts of that process,” Milgram said.

‘Evidence Supports Marijuana for Pain’

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – may be historic, but it’s not the full “legalization” that many cannabis supporters have been calling for.  

Under the CSA, legal access to Schedule III substances requires a prescription from a licensed doctor that is filled at a licensed pharmacy. Any new medical marijuana products would also have to go through a lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would likely only be approved by FDA for certain conditions.  

Garland’s notice in the Federal Register is largely based on the FDA’s 2023 review, which states there is good evidence that marijuana is helpful in treating chronic pain and mixed evidence it could be useful in relieving nausea, anxiety, epilepsy and PTSD.

“FDA’s review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). Numerous systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for chronic pain,” Garland wrote.

As for marijuana’s potential for abuse, Garland cited findings that marijuana poses less of a health risk than illicit drugs and even some legal medications such as oxycodone and benzodiazepines.

“The rank order of the comparators in terms of greatest adverse consequences typically ranked heroin, benzodiazepines, and cocaine first or in immediately subsequent positions, with marijuana in a lower place in the ranking,” Garland wrote.

“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time. HHS thus concluded that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The opening of a public comment period does not mark the end of the rescheduling process. The DEA/DOJ will need time to review and evaluate thousands of comments, which will be followed by an administrative hearing and a final ruling that is subject to presidential review. Even then, the final rule has to be published in the Federal Register, followed by a 30 or 60-day wait period before the rule takes effect. 

During that process, and until a final rule is published, marijuana remains a schedule I controlled substance that is illegal under federal law. About three-quarters of states have already legalized marijuana for medical or recreational purposes.

U.S. Drug Shortages Reach Record Levels

By Pat Anson, PNN Editor

Shortages of opioids and other medications reached a record level in the U.S. during the first quarter of 2024, according to the American Society of Health-System Pharmacists (ASHP). The 323 medications listed in short supply are the highest number since the ASHP began tracking drug shortages in 2001.

Some of the most acute shortages are for basic, life-saving injectable drugs used in hospitals for pain control, sedation and chemotherapy.

Most of the drug manufacturers contacted by the ASHP did not provide a reason for the shortages, but some blamed supply/demand issues (14%), manufacturing problems (12%), business decisions (12%) and raw material issues (2%).

The ASHP also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have curtailed the supply of opioid medication at many pharmacies.

“New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances,” the ASHP said in its latest report.

The Drug Enforcement Administration has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. The DEA says it acts on the advice of the Food and Drug Administration, which projected a 7.9% decline in the “medical need” for opioids in 2024, months before the new year even began.

Many pain patients question whether the demand for opioids is really going down. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy. Nearly 20% were unable to get their pain medication, even after contacting multiple pharmacies.

“The pharmacist said they could not get my medication because the supplier informed them that they had reached their yearly max and the DEA would not let them supply anymore medication,” one patient told us.

“I am terrified of the cuts being pushed by the DEA,” said another patient. “Several times I have had to wait over a week until my local CVS got my medication back in stock. Honestly, I have such intolerable pain I had no choice but to turn to illicit street drugs to fill in the gaps.”

Shortages of stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) get far more attention than shortages of opioids, which the FDA and DEA have largely ignored. The DEA modestly raised production quotas for ADHD drugs in 2024, but they remain in short supply.

About 12% of the 323 drugs currently listed in shortage by the ASHP are controlled substances regulated by the DEA because they are potentially addictive.

University of Utah Drug Information Service

“I can’t say for sure that every single controlled substance shortage is due to quota issues, but it’s a contributing factor for some,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “DEA changed their quota process to try to help with ADHD drug shortages, but didn’t take into account how their change affects injectable manufacturers.”

Fox shared a recent letter sent by Pfizer to U.S. hospitals warning of “additional supply interruptions and potential stock outs” due to DEA quota changes. The letter warns of limited supplies of several injectable medicines made by Pfizer, including meperidine (Demerol), hydromorphone and morphine.  

“I understand that DEA is working to prevent drug diversion and was under fire for the ADHD medication shortages, but injectable manufacturing is very different than oral products and DEA did not take into account all of the special processes that are required for injectables,” Fox said in an email to PNN.

Nearly half of the drugs on the ASHP’s shortage list are injectables. Opioids, stimulants and other drugs that affect the central nervous system are the leading class of medication in short supply, followed by antibiotics, hormonal agents, and chemotherapy drugs.

The FDA, which uses a different system to track drug shortages, currently lists only 153 medications in short supply, less than half the number listed by the ASHP.

Study Finds CBD Ineffective for Chronic Pain

By Pat Anson, PNN Editor

There is little evidence that cannabidiol (CBD) products relieve chronic pain and some could be potentially harmful to patients, according to UK and Canadian researchers.

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Often marketed as a pain reliever, CBD can be purchased in edibles, beverages, lotions, oils and other products, usually without a prescription.  

“CBD presents consumers with a big problem,” says lead author Chris Eccleston, PhD, Professor of Pain Science at the University of Bath in the UK. “It’s touted as a cure for all pain but there’s a complete lack of quality evidence that it has any positive effects.

“There should be no excuses for misleading the public, and yet it is likely that the public is being misled and possibly placed in harm’s way.”

Eccleston and his colleagues reviewed the results of 16 high-quality clinical trials of CBD products, involving over 900 participants. Their findings, published in in The Journal of Pain, show that CBD provided little or no pain relief in 15 of the 16 studies. The one small trial that did showed improvement in arthritis pain after two weeks of treatment with a topical CBD lotion.

Just as concerning to researchers is that many CBD products sold directly to consumers have significantly more or less CBD than what their labels indicate. Some CBD products also contain THC, when they weren’t supposed to have any.

“There is no good reason for thinking that CBD relieves pain, but there are good reasons for doubting the contents of CBD products in terms of CBD content and purity,” Eccleston wrote. “Regulatory authorities should also take note of the considerable deficiencies existing in the products sold, especially the incorrect labeling of many products, and possible contamination with psychoactive compounds.”

The researchers say regulators in the US, UK and Canada are often slow to respond to the false medical claims of some CBD manufacturers. The FDA occasionally sends warning letters to companies making unsubstantiated claims about CBD, but it rarely results in fines or disciplinary action.

“What this means is that there are no consumer protections,” said co-author Dr Andrew Moore, Director of Pain Research at the University of Oxford. “And without a countervailing body to keep the CBD sellers in check, it’s unlikely that the false promises being made about the analgesic effects of CBD will slow down in the years ahead.”

In a recent review, the FDA said there was “credible scientific support” for cannabis as a pain reliever and recommended that the DEA reschedule it as a Schedule III controlled substance. Such a move would make it legal under federal law for cannabis to be prescribed for medically approved conditions, but would have no impact on CBD products.

In 2022, FDA Commissioner Dr. Robert Califf asked Congress to give his agency the authority to more closely regulate CBD, but no such legislation has been passed. Eccleston says its part of a pattern in which pain sufferers are neglected and left on their own to find relief.

“It’s almost as if chronic pain patients don’t matter, and that we’re happy for people to trade on hope and despair,” he said.

‘Smart Opioid’ Relieves Pain with Lower Risk of Overdose

By Pat Anson, PNN Editor

An experimental form of hydrocodone relieves moderate-to-severe acute pain without the risks of traditional opioids, according to the results of an early-stage Phase 1 clinical trial.

Elysium Therapeutics say its proprietary “SMART” formulation of hydrocodone – called Oral Overdose Protected (O2P) hydrocodone – releases therapeutic levels of the pain medication when exposed to trypsin, a digestive enzyme in the small intestine. Conversely, the drug can also inhibit production of trypsin – and slow the release of hydrocodone -- if a "supratherapeutic" (more than recommended) dose is ingested.

In theory, that will reduce the risk of abuse, diversion and overdose.

"Because non-opioid options are ineffective and existing opioids have no protection against their inherent risks, moderate-to-severe acute pain is not adequately managed in greater than 80% of patients in the US,” Greg Sturmer, CEO of Elysium Therapeutics said in a press release.

“As shown in our human study, our SMART opioids, led by O2P hydrocodone, mitigate the major risks associated with existing prescription opioids without sacrificing their superior analgesic efficacy, especially when compared to currently marketed non-opioid alternatives and those in development."

The proof-of-concept study included 93 healthy participants who were not in pain, but had previously used and tolerated prescription opioids. Their blood plasma levels were measured after taking O2P hydrocodone and compared to plasma levels after taking traditional hydrocodone. Participants were also given naltrexone as a safety measure to block the sedative effect of the drugs.

Investigators say the plasma concentrations of hydrocodone were significantly lower after taking the O2P formulation, but were high enough to be “potentially lethal” from traditional hydrocodone. No adverse events were reported from O2P hydrocodone, even when taken at supratherapeutic doses.

"The results from the O2P-001 study indicate that Elysium's O2P technology could yield safer opioids that address the key issues inherent in current opioids that have fueled the opioid crisis, while providing patients with highly effective pain relief," said Leela Vrishabhendra, MD, principal investigator of the study.

Many U.S. hospitals have started using non-opioid pain medications such as ibuprofen, acetaminophen and gabapentinoids to treat post-operative acute pain. Studies have found that some patients are not happy with the results and want more pain control. O2P hydrocodone would give them an alternative.

Phase I clinical studies are preliminary in nature and usually just measure the safety and tolerability of a drug, not its effectiveness. Elysium hopes its findings will lead to a “breakthrough therapy” designation from the FDA, which will speed up the development of its O2P technology and lead to larger clinical trials that would better assess pain relief.   

"Given the robust Phase 1 human proof-of-concept data, we plan to meet with the FDA to discuss next steps, finalize our dose form for remaining clinical studies, and seek partners and investors who share our passion to disrupt the pain and opioid use disorder markets with safer medicines that reduce trauma and save lives," said CEO Greg Sturmer.

How Does Kratom Relieve Pain?

By Dr. C. Michael White, University of Connecticut

Kratom doesn’t contain just one active ingredient; rather, it is made up of many substances that induce effects in the body. This is very common for natural products, since the cells of the plant make a variety of chemicals for different purposes.

When the body is experiencing pain, it releases hormones called endorphins that stimulate opioid receptors to mildly reduce the transmission of local pain sensations to the brain. This same process also causes the release of the neurotransmitter dopamine, inducing a feeling of pleasure to neutralize the pain.

Traditional opioids, like morphine and fentanyl, stimulate these same receptors to such a degree that they more potently numb pain, induce a euphoric feeling that can lead to addiction, and suppress the drive to breathe, which can result in death.

One of the key constituents of kratom is an organic compound called mitragynine. It interacts with the same opioid receptors as morphine and fentanyl, but does not recruit the beta-arrestin-2 (the reason for breathing suppression). As a result, kratom can provide pain relief with a lower risk of slowed or stopped breathing compared to traditional opioids.

Kratom also contains a small amount of 7-hydroxymitragynine, which is thought to more potently stimulate opioid receptors, leading to a greater risk of opioidlike adverse events.

One of the risks associated with kratom use is that products can differ dramatically in the doses of 7-hydroxymitragynine. In other words, one kratom product could be more dangerous than another. When kratom is used in high doses, it can lead to seizures and other issues. Since kratom products are not FDA-regulated, there is no uniformity to the products.

Is Kratom Legal?

Kratom’s current legal status is complicated. Kratom is not a prescription or over-the-counter drug, and while it is derived from a plant, it does not meet the FDA’s definition of a dietary supplement, food or food additive.

Natural products marketed in the U.S. before Oct. 15, 1994, were grandfathered in under the FDA’s list of dietary supplements. But since kratom came on the market later, the FDA would have to find, based on a history of use or other evidence, that when used under the conditions recommended or suggested in the labeling, the natural product can reasonably be expected to be safe – like the FDA does for all new dietary supplement ingredients.

In 2016, in response to increasing calls to poison control centers, the Drug Enforcement Administration sought to ban kratom by making it a Schedule I drug. This means the agency felt it had no currently accepted medical use and a high potential for abuse. But backlash from the public and support from congressional members made the agency postpone a final decision. So kratom is currently listed as a “drug of concern.”

Seven states and some counties have banned the sale of kratom. But in 2023, the U.S. House and Senate proposed legislation to prevent the FDA from regulating kratom more stringently than they do a dietary supplement or a food additive, in order to keep the product accessible to consumers.

Kratom Research Lacking

A 2024 literature review concluded that there are no clinical trials evaluating the effects of kratom on chronic pain management.

Research on acute pain tolerance in people is limited to a 2020 study that found participants who took a dose of kratom could endure immersion of their arms in an ice bath for significantly longer than those who did not take a dose of kratom. However, this study was conducted on chronic kratom users, and their pain tolerance before they took their dose for that study was much lower compared to that of non-kratom users in other studies. This suggests that chronic kratom use is lowering people’s background pain tolerance.

This is similar to another study showing that when people tried to stop taking kratom after chronic use, they experienced significant pain throughout their body. This increased sensitivity and reactivity to pain, called hyperalgesia, also occurs with traditional opioids and is one of the reasons why people who use them chronically find it so difficult to get off them.

Taken together, these studies suggest caution before starting kratom as a treatment for chronic pain, especially if safer methods such as acetaminophen, icing and heating, and physical therapy can suffice.

Some people also claim that kratom could be a natural treatment for withdrawal and other effects of opioid use disorder, the clinical term for opioid dependence.

A few methodologically weak studies reported that participants were able to reduce or stop their use of traditional opioids and that kratom reduced the severity of opioid withdrawal symptoms. These include diarrhea, runny nose and eyes, shaking, fast heartbeat and anxiety.

However, there are no clinical trials comparing kratom to methadone, buprenorphine or naltrexone, the FDA-approved treatment options for opioid use disorder. So if patients have access to traditional FDA-approved therapies, these are the safest and best place to start.

If traditional options are not effective or patients cannot access them due to financial or logistical barriers, kratom may be a potential alternative to illegal opioid products, but it is certainly not risk free. Speaking with a health care professional is critical before making treatment decisions.

C. Michael White, PharmD, is a Distinguished Professor and Chair of the Department of Pharmacy Practice at the University of Connecticut School of Pharmacy. He has been studying the science behind kratom to help consumers better understand its potential benefits and adverse effects.

White’s research work has been funded by the Agency for Healthcare Research and Quality (AHRQ), Donaghue Foundation, Pfeiffer Foundation, and American College of Clinical Pharmacy.

This article originally appeared in The Conversation  and is republished with permission.

FDA Finds ‘Credible Scientific Support’ for Marijuana as Pain Reliever

By Pat Anson, PNN Editor

It took a lawsuit to prompt its release, but the U.S. Department of Health and Human Services (HHS) has finally made public a lengthy FDA review explaining why it thinks marijuana should be rescheduled as a Schedule III controlled substance. Such a move would make it legal under federal law for marijuana to be used for medically approved purposes, such as pain relief.

The FDA review was completed last August, nearly a year after it was requested by President Biden. But the 252-page review was not released until Friday, after a lawsuit was filed by two pro-cannabis lawyers when HHS didn’t respond to Freedom of Information Act (FOIA) requests.

Medical marijuana is already legal in 38 states, but cannabis remains classified as a Schedule I substance by the Drug Enforcement Administration, making its sale or use illegal under federal law. The DEA is expected to make its decision on rescheduling soon.

The FDA looked at seven potential medical uses of cannabis: pain, anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and post-traumatic stress disorder (PTSD).

After reviewing clinical studies of cannabis, and the views of academic and professional medical societies, the FDA said they found “mixed findings of effectiveness.” The strongest evidence was for pain relief, anorexia and nausea.

“The available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain.”

— FDA review

“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain),” the FDA said. “On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings.”

Perhaps just as importantly, the FDA found no evidence of “unacceptably high safety risks” when marijuana was used therapeutically. That is a key finding for marijuana to be rescheduled by the DEA. The risk of marijuana being used nonmedically was also low, compared to substances like alcohol, heroin, cocaine, prescription opioids and anti-anxiety drugs.

“The rank order of the comparators in terms of greatest adverse consequences typically places heroin, benzodiazepines and/or cocaine in the first or immediately subsequent positions, with marijuana in a lower place in the ranking, especially when a utilization adjustment is calculated. For overdose deaths, marijuana is always in the lowest ranking among comparator drugs,” FDA said.

“These evaluations demonstrate that there is consistency across databases, across substances, and over time that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The FDA said the “vast majority” of professional medical organizations do not recommend marijuana, but they don’t specifically recommend against it either. The lone exception is the American Psychiatric Association, which warns that long-term use of marijuana can worsen psychiatric conditions, such as paranoia and hallucinations.

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – would certainly be historic, but it won’t resolve the many differences between federal and state regulation of cannabis.

Under federal law, legal access to Schedule III substances requires a prescription from a licensed doctor that is dispensed from a licensed pharmacy. Medical marijuana products would also have to go through the FDA’s lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would only be approved by FDA for certain conditions.  

Lax FDA Oversight of Medical Devices Exposed in Lawsuits

By Fred Schulte and Holly K. Hacker, KFF Health News  

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

CARLA WIGGINS AND CARLTON GAUTNEY

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

• Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.

• Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.

• Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.

• And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed for this article.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall.

More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

MiniMed 670G insulin pump (MEDTRONIC IMAGE)

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data.

Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.”

The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show.

In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused. According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit. In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021. One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.”

For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘New and Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

FDA Approves Genetic Test for Opioid Addiction Risk

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial genetic test that uses a patient’s DNA to assess whether they are at risk of developing opioid use disorder (OUD).  

Although the test is only intended for patients with short-term acute pain who have not used opioids before, there is concern about the test’s accuracy and whether it will be used “off-label” to assess addiction risk in chronic pain patients – who could potentially lose access to opioids as a result.

In approving the AvertD test, the FDA stipulated that it only be available by prescription to patients who consent to its use and have no prior history of using an oral opioid for pain relief.

The test is administered by a provider swabbing the cheek of a patient to collect a DNA sample, which will then be tested in a laboratory to see if the patient has 15 genetic markers that puts them at elevated risk of OUD.

According to the FDA, the test will help patients “make better informed decisions” about opioids, such as a patient facing surgery who wants to know what analgesic to use for acute post-operative pain.

AUTOGENOMICS IMAGE

"AvertD may help patients who are concerned about being treated with an opioid for acute pain,” Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a statement. “The test is not intended to be used in patients being treated for chronic pain.”

But given the history of opioid guidelines being mistakenly applied to all kinds of patients, regardless of their condition, some worry the test will be misused.

“I’m sure it would be used for anyone who may be considered for opioid therapy,” says Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy. “I am all for gathering more data to help clinicians make better decisions, but we must exercise caution with such tests. Otherwise, the test may be over-read or misinterpreted. Some patients may be deprived of access to an opioid if they test positive or there can be a false sense of harmlessness from opioids if the test is negative. 

“I am most concerned that providers will see the results as binary. Either a patient will or won’t develop OUD, depending on the result. That would be a big mistake. Any such device or test must be used along with other clinical and personal information to help mitigate harm from using, or being denied, opioids.”

80% Accuracy

As part of its approval order, the FDA is requiring AutoGenomics – the company that makes AvertD – to provide training to healthcare providers on the proper use of the test and to conduct a post-market study of its performance and accuracy.

In 2022, an FDA advisory committee voted 11-2 against recommending an earlier version of AvertD, primarily because of concerns about false-negative and false-positive results. An observational study found the test was about 80% accurate in detecting genes associated with OUD.

"I believe 100% of the risk associated with this test is with false positives and false negatives -- both people being untreated or poorly treated because somehow it came back as a positive result, or being given inappropriate treatment because it said negative," said Timothy Ness, MD, an anesthesiologist and Professor Emeritus at the University of Alabama at Birmingham, an advisory panel member who voted no.

After the advisory committee vote, the FDA worked with AutoGenomics to modify the test and improve its accuracy. The company then submitted a premarket approval application for the modified test, which the FDA granted without going back to the advisory committee for further review.

“The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks. Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD's safety and effectiveness,” said Dr. Shuren.

But no test is foolproof in either its accuracy or implementation, as Dr. Webster learned when he developed a questionnaire that assesses addiction risk by asking patients about their family history and other potential risk factors. Webster was disappointed to learn his questionnaire was “weaponized” by some providers to deny opioid therapy to patients, particularly women with a history being sexually abused.

Webster says the risk of OUD can’t be measured by a genetic test alone.

“We should not think it is a diagnostic tool or a crystal ball. Having an increased risk due to genetics does not mean that, if exposed to an opioid, an individual necessarily will develop an opioid addiction,” Webster told PNN. 

“We have known for a long time that about fifty percent of the risk of developing an opioid addiction is due to genetics. The other fifty percent is due to environmental factors and life’s experience. Furthermore, people can develop OUD without genetic risks. OUD risk is dynamic, meaning it changes over time with adverse events in life and often co-morbid conditions. For example, there was a surge in all forms of drug abuse, including OUD, during the pandemic because of isolation and loneliness. This is not detected by a genetic test.”

Although the risk of a surgery patient misusing opioids or becoming addicted is low – less than one percent -- the parent company of AutoGenomics has a more stark assessment, calling surgery “a gateway to addiction” that puts another 7 million Americans at risk every year.

Herbal Pain Relief Tea Recalled for Having Undeclared Drugs

By Pat Anson, PNN Editor

“Alleviates Pain & Inflammation Within 10 Minutes”

“Drug-Free All Natural Herbal Pain Relief”

As the saying goes, if the ads sound too good to be true, they probably are. Especially the part about being “drug-free.”

An herbal tea being marketed as a pain reliever for arthritis, gout, fibromyalgia and migraine is being voluntarily recalled after the Food and Drug Administration found that it contained “undeclared drugs.”

WS Global, a New York-based distribution company, is recalling all packages of Himalayan Pain Relief Tea after being informed by the FDA that the tea contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone, a corticosteroid.

The company said it had not received any reports of adverse events involving the tea, but urged consumers to “immediately consult their health care professional” if they consumed it.

In a news release, the FDA said diclofenac may raise the risk of cardiovascular events, such as a heart attack or stroke, and could interact with other medications.

Dexamethasone can suppress the adrenal gland, impair a person’s ability to fight infections, and cause high blood sugar, muscle injuries and psychiatric problems. It may also have serious side effects when combined with other medications.

Neither diclofenac or dexamethasone are mentioned on the tea’s product label or advertising. The company claims the tea was “formulated by a traditional comprehensive recipe from the Himalayan monks.”

Himalayan Pain Relief Tea was being sold online, primarily through Amazon.

This is not the first time that an herbal or dietary supplement sold by Amazon was recalled due to undeclared drugs, contamination or other health concerns. In recent months, recalls were also ordered for a male sexual enhancement product, a glucose supplement, apple sauce, and an anti-cavity mouthwash for kids. All were being sold on Amazon.  

In a recent warning letter to Amazon’s CEO about selling several brands of unapproved eye drops, the FDA said the company should take more responsibility for the products it sells.

“The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” said Jill Furman, Director of the FDA Office of Compliance, Center for Drug Evaluation and Research.

Amazon complied with that request by removing the eye drops from its online marketplace.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations,” the company said in a statement.

Amazon received a similar warning letter in 2022, for selling a “misbranded” dietary supplement for arthritis that was linked to liver toxicity and at least one death. That product also contained diclofenac and dexamethasone.

You can still find Himalayan Pain Relief Tea on Amazon, with a notation that it is “currently unavailable.”

“We don't know when or if this item will be back in stock,” Amazon cautions potential buyers.

Patients Urge DEA to Stop Cutting Supply of Opioid Pain Medication

By Pat Anson, PNN Editor

Thousands of people in pain are urging the Drug Enforcement Administration to scrap plans to further reduce the supply of opioid medication in 2024.

The DEA recently announced it would cut production quotas for oxycodone, hydrocodone, codeine and other opioids for the 8th straight year, despite complaints from pain patients and healthcare providers that the medications are already in short supply and difficult to get at pharmacies.

The DEA invited people to comment on its plans in the Federal Register. Over 2,400 have so far – many with heart breaking stories to share about not being able to get the pain medication they need.

“I was finally able to establish a reasonable pain management routine but that was disrupted when my regular pharmacy was no longer able to supply my medication (a moderate dose of Norco) and not a single other pharmacy was willing/able to fill my prescription,” said Jessica Ericksen. “One pharmacy supervisor screamed at my doctor on the phone when he called in to try to get my prescription set up with them. I now have a 1.5 hour round trip drive to get my medication, which is particularly challenging for a disabled person who is unable to drive.”

“I am one of the many that has had my life destroyed by the government regulations on pain meds. I haven't been able to get my medications for the better part of a year,” said Paula Perry. “I'm now basically bedridden and praying for death. Stop doing this to people, we are dying and you guys make it worse every year.”

“Most of us in pain have gone through all of the other drugs to treat our pain and these are the drugs of last resort. The opioids don't totally treat our pain but allow us to function,” said Heather Larson. “The DEA needs to stop playing doctor and let the doctor decide what is right to prescribe. If production is cut anymore, people will commit suicide or go to the street for pain medication.” 

“I have already had to jump through numerous hoops just to be prescribed my meds, but now have to call pharmacy after pharmacy monthly to find my meds, because they are out of stock at every pharmacy around me in a 10-mile radius,” said Jill Bartruff, who suffers from scoliosis. “I also had a surgery in September 2023 and could not find a pharmacy to fill my post op pain meds. I was in immense pain and was unable to advocate for myself to get my meds filled. Imagine being cut open and discharged from the hospital with no pain control.”

“Why do you continue to cut supply when legitimate patients cannot obtain their medications? Many are already out of their meds for weeks on end,” an anonymous poster wrote. “You should be able to see you're making the situation worse.” 

‘More People Will Die’

Why is the DEA planning to reduce the opioid supply for yet another year? The agency wants to reduce the risk of opioid addiction and overdose, and is relying on advice from the Food and Drug Administration, which estimates that medical demand for Schedule II opioids will decline 7.9% from 2023 levels.

But opioid production quotas have been falling for nearly a decade and overdoses have still risen to record levels – fueled primarily by illicit fentanyl, stimulants and other street drugs. 

“The proposed quota will, without any doubt, not only cause harm but actually kill people. Research has shown time and time again that restricting access to safe, regulated supplies of opioids does not result in decreased use, but rather increased reliance on an unstable, unregulated street supply,” Alexandra Bradley wrote in her comment. “The DEA is making a massively dangerous move by even suggesting this quota, and it will result in the deaths of many, many people.” 

“Further reduction of chronic pain relief meds such as oxycodone will literally add to the body count (mostly suicide and withdrawal from abruptly stopping meds) already racked up due to the ongoing shortages,” said Ronald Crook Jr. “What an embarrassment and shame that chronic pain patients such as myself who are just trying to maintain some sense of dignity face being told by our pharmacist that the wealthiest, most powerful nation on earth cannot help us because of quotas.”

“All of us patients, we are the compliant ones with our medications. We go through extensive pill counts and urine drug screens to make sure we are not abusing the substance. The overdoses that are occurring are due to heroin and fentanyl, not prescribed pain medication,” said Candace McFarland. “If you choose to cut people’s medications, more people will turn to the street and more people will overdose accidentally on fentanyl.”

“Individuals that are prescribed pain medication already have a hard enough time getting their medications. I can sympathize. I have ADHD and I've been on Adderall for the better part of a decade. And this year every refill day was anxiety inducing because of the shortage,” said Amber Kunkel. “There needs to be an increase in producing both pain medications and ADHD meds. Without access to safe and predictable drugs, there will be a continued increase in people turning to the streets for medication and dying.” 

The DEA and FDA have responded to complaints of Adderall shortages and other stimulants used to treat attention-deficit/hyperactivity disorder. The DEA plans to modestly raise production quotas for stimulants, after the FDA predicted a 3.1% increase in their medical use in 2024.  

But both federal agencies appear to have turned a blind eye to opioid shortages. The American Society of Health-System Pharmacists (ASHP) has been warning of shortages of oxycodone and hydrocodone for months, but those shortages have not been publicly acknowledged by either the DEA or FDA.

Other factors that could be contributing to opioid shortages are strict limits on the amount that can be supplied to pharmacies – regardless of patient need -- under the national opioid settlement. A suspicious order or “red flag” activity could result in a pharmacy being terminated from receiving anymore controlled substances -- putting added pressure on pharmacists to carefully screen patients and their prescriptions.

Another factor is the low cost of generic opioids. Prices for some generic medicines are so low that some manufacturers can’t make a profit and have stopped making the drugs. Other manufacturers can’t raise production of opioids without permission from the DEA.

‘Great Potential’ in Stem Cell Therapies for Knee Osteoarthritis

By Pat Anson, PNN Editor

Osteoarthritis of the knee is one of the most common forms of arthritis, causing progressive damage and thinning of cartilage in the knee joint.  Over 32 million American adults have knee osteoarthritis (OA), but most are treated with injections or pain medications that provide only temporary relief and often have side effects.

Could stems cells provide a more effective and long-lasting treatment for knee OA? Clinical trials have had mixed results so far, so a group of researchers in China conducted a meta-analysis of nearly 1,200 studies, weeding out the ones that were poorly designed or biased.

They eventually settled on 16 studies involving 875 patients with knee OA, most of them high quality studies that were randomized with control groups to compare results with.

Their findings, published in the Journal of Orthopaedic Research, show that stem cell treatment was associated with significant reductions in patient-reported pain from the third month onwards.

The most pain relief came from mesenchymal stem cells (MSCs) derived from a patient’s own body fat (adipose tissue) and stem cells derived from umbilical cord blood. Injections of MSCs derived from a patient’s fat provided better pain relief than stem cells from other donors and led to the most recovery of knee joint function.

“Stem cell transplantation proved safe and effective for knee osteoarthritis treatment,” the authors wrote. “Different sources of stem cells have a good effect on alleviating knee joint pain, restoring knee joint function, and minimizing patient trauma.”

The researchers said there was “great potential” for MSC therapy in the treatment of knee OA, but larger studies were needed to confirm their findings.

“The safety and efficacy of MSC therapy require rigorous validation with a larger sample size before clinical application. From the perspectives of relieving knee joint pain, promoting knee joint function recovery, and reducing patient trauma, umbilical cord‐derived stem cells should be considered as a priority option, followed by ADSCs (adipose stem cells), and finally bone marrow‐derived stem cells.”

In 2019, a small Canadian study found that stem cells collected from a patient’s bone marrow significantly reduced knee pain from osteoarthritis for as long as a year. But that study only involved 12 patients.

FDA Foot Dragging

Why are there so few good quality studies? Stem cell promoters have long complained about foot dragging by the Food and Drug Administration, which has been reluctant to approve new stem cell therapies that are not tested in randomized, double-blind, placebo-controlled studies — the so-called “gold standard” in clinical trials.

The FDA sent warning letters to 20 stem cell manufacturers and clinics in 2019, saying they were in violation of FDA guidance requiring stem cells to undergo “minimal manipulation.” The agency said the science behind stem cells made from a patient’s own tissue had not been proven safe and effective.

“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation,” then FDA commissioner Scott Gottlieb, MD, and FDA Biologics Center Director Peter Marks, MD, said in a joint statement.

Critics say the FDA is still slowing down stem cell research, despite a pledge to approve 10 to 20 cell or gene therapies annually by 2025. So far this year, the agency has only approved five.  

“Despite signs of progress and a strong commitment from FDA leadership to improve its readiness for these cutting-edge therapies, the agency remains far off pace. Its risk-averse approach and culture that’s slow to adapt to new science could become a curse for many patients and the scientific field as a whole, with investment in biotech chilling in recent quarters,” Richard Burr, a policy adviser for health and life sciences consultant DLA Piper, wrote in an op/ed published in STAT News.

Burr is a former U.S. senator and congressman from North Carolina.

“During my time in Congress, I was one of the FDA’s toughest critics, but I also fiercely defended its mission because I believe in it. The FDA now has an opportunity to transform its oversight of cell and gene therapies and deliver on promises made to patients,” Burr said.