Judge Says FDA Can Stop Clinic from Selling Stem Cell Treatments

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The decision may facilitate the agency cracking down more effectively on the unproven interventions these companies sell.

By Emma Yasinski
June 7, 2019

 In 2015, a stem cell clinic in Florida conducted a procedure on three women to treat their macular degeneration. Instead, it left each of them with severe vision loss. The tragedy has been held up as an example of the lack of regulatory oversight the US government has had over such outfits that offer unproven stem cell treatments—and now, it’s an example of how that is changing.

On June 3, a federal judge ruled that the US Food and Drug Administration (FDA) is entitled to a permanent injunction against US Stem Cell, forcing the company to stop conducting procedures using a particular technique that involves isolating stem cells from clients’ fat.

The FDA also filed a suit against a California-based company Cell Surgical Network, which provides similar interventions, that is still pending in court.

“The lawsuit itself wasn’t surprising. The allegations weren’t surprising. And the judge’s conclusion wasn’t very surprising,” Andrew Ittleman, an attorney at Miami-based Fuerst, Ittleman, David & Joseph, a law firm that counts government compliance for stem cell and regenerative medicine companies as one of its key practice areas, tells The Scientist. “If anything, people were wondering why it took so long.”

Hundreds of stem cell clinics have popped up across the US and other countries in recent years, making promises with little evidence that their treatments can cure ailments that traditional medicine cannot. The clinics have often avoided FDA oversight by claiming that their procedures, which often use a patient’s own cells, are not subject to FDA regulations.

The agency has been cracking down on the industry, but it has only successfully obtained a judgment against a stem cell clinic once before. This latest ruling by Judge Ursula Ungaro of the United States District Court for the Southern District of Florida may represent a sea change in regulatory enforcement, and possibly open the door for the FDA to file suits against companies violating FDA guidelines for marketing stem cell treatments en masse, according to Ittleman.

“This is a landmark decision because this is only the second time the FDA has obtained a judgment against a stem cell clinic, and the first judgment since FDA announced in 2017 the agency’s risk-based enforcement priorities for regenerative medicine,” FDA spokesperson Stephanie Caccomo tells The Scientist in an email.

See “Texas Stem Cell Law Opens Door for Controversial Treatments”

 Research on stem cell therapies has ballooned in recent years, and some procedures for certain blood disorders have even been FDA-approved, but most remain unproven as far as the FDA is concerned. Extracting fat cells using liposuction, processing them to extract stem cells (known as stromal vascular fraction cells or SVF), and injecting them into other areas of the body— the strategy US Stem Cell uses—has been an FDA target before. Some clinics provide treatments with stem cells derived from bone marrow, cord blood, or birth tissue.

Ittleman, who has represented clients sued by the FDA, doesn’t believe the ruling will immediately affect clinics using other types of stem cells. “The fat [derived stem cell treatment] has been really the one place where the FDA has been very clear for very long about its position. We don’t necessarily have that clarity in other areas,” he says. The ruling may inspire the FDA to target other unapproved stem cell treatments with litigation, he adds.

The three patients who lost all or most of their sight were the first (and only) three participants in a discontinued clinical trial US Stem Cell was running on the procedure. Afterward, the patients saw university-based ophthalmologists for treatment, and those doctors published a report in March of 2017 in the New England Journal of Medicine detailing the adverse effects on each individual and raising concern about stem cell clinics.

US Stem Cell failed to follow best practice in ophthalmology of operating on one eye first, and returning later for a second surgery on the remaining eye. This way, if there is an adverse reaction, the patient can still see with the untreated eye. But the company conducted both procedures simultaneously.

Shortly after the failed procedures, two of the patients settled lawsuits with US Stem Cell, but the company faced few other penalties. While it stopped offering fat-derived stem cell treatments for macular degeneration, it continued to provide services using SVF that it claimed could treat myriad ailments, from Parkinson’s disease to chronic obstructive pulmonary disease (COPD).

The FDA sent a warning letter to US Stem Cell in August 2017 about marketing the unapproved products and violations to good manufacturing practices. But the company did not comply. Ittleman says they were “really sticking their fingers in the FDA’s eyes over the course of time saying, ‘You don’t regulate us.’”

In a written statement sent to The Scientist, US Stem Cell said, “While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision.” A spokeswoman told The New York Times that the company plans to continue offering stem cell treatments derived from other tissue.

“Precedent from cases like this helps the FDA in future enforcement actions,” says Caccomo. “The FDA will continue to take steps—such as issuing warning letters or initiating court cases—against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use.”

Click here to read the full article.

Approval of Epidiolex, a Cannabis derived drug for the treatment of Seizures

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By Jane Clarke
April 16, 2019

Epidiolex became the first cannabis-derived medication to be approved by the FDA in June of this year. It is used to treat two types of serious childhood epilepsy from the British organization GW Pharmaceuticals. The Food and Drug Administration approved the drug for sale in the US on Monday. It will probably be available in pharmacies by prescription.

Epidiolex contains a chemical compound, cannabinoid otherwise called CBD. It is popular for its reported abilities to help relief from illnesses, for example, anxiety, joint pain, a sleeping disorder, and nausea.

Moreover, epidiolex is useful in treating an uncommon type of epilepsy called Lennox-Gastaut Syndrome (LGS) and a genetic brain dysfunction known as Dravet syndrome. According to CNN, the two disorders can cause seizures. In any case, Epidiolex, with its cannabis derivatives, has been found to reduce a particular kind of those seizures by as much as 25% to 28%.

FDA endorsed the medication back in April, but GW couldn’t sell it. The reason is the DEA has regarded cannabis a Schedule I drug alongside heroin, LSD, and cocaine. It means it is considered to have “no currently accepted restorative use and a high potential for abuse.” Now, Epidiolex specifically — however not CBD or cannabis — is Schedule V. “The DEA is stating, ‘if you’ve satisfied FDA, you’ve satisfied us,’” says Andrew Ittleman, a partner of the law firm FIDJ. It’s appearing “considerable amount of deference” to the FDA.

The Cooperation of DEA with Researchers:
The Department for Drug Enforcement (DEA) says it will work with the researchers to help them in their research. Marijuana and CBD got from cannabis stay unlawful in the United States except if they are in items endorsed by the FDA, for example, Epidiolex. Researchers are conducting more research into the medical benefits of cannabis.

“DEA will keep on supporting sound and logical research that advances legitimate therapeutic uses for FDA-approved components of cannabis, consistent with the federal law,” said Acting DEA Administrator Uttam Dhillon in a written proclamation. “DEA is focused on proceeding to work with our federal partners to look for approaches to make the procedure for research progressively proficient and effective.” The greatest unknown is how insurance agencies will choose to cover Epidiolex.

The double-blind, placebo-controlled trials required for FDA endorsement just covered two rare types of epilepsy—Dravet Syndrome and Lennox Gastaut Syndrome. Around 50,000 patients are suffered by these two diseases. However, there is evidence that Epidiolex could help with many distinctive kinds of seizures and epilepsy syndromes.

Without a doubt, 66% of the 1,756 patients who have attempted Epidiolex in the previous five years didn’t have Dravet or LGS. Epidiolex demand was so high among medication inert patients like Sam that GW permitted neurologists at almost four dozen hospitals that weren’t a part of the formal trials to direct their own so-called open-label trials. It helped GW to study more about how Epidiolex functioned in a more extensive population. It allowed many sick patients to gain access to medication that may help them.

That parallel research should make it simpler for specialists to suggest the medication for different diseases, a training known as “prescribing off label.”

To conclude, the expectation among CBD advocates is that the FDA’s endorsement could goad more investigation into medicinal cannabis items, however, weed itself stays illicit.

Although therapeutic or medical cannabis is accessible in about half of U.S. states. But federal regulations still characterize CBD as a Schedule 1 medicate, which implies it has no therapeutic value however it has a high potential for abuse since it is a chemical component of the cannabis plant.

Are You Eligible for Tax Savings with the Home Office Deduction?

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If you conduct some or all of your business from home, you may want to look into a home office deduction this tax season.

By Julie Bawden Davis
February 22, 2019

Do you use part of your home for business purposes? If so, you may be eligible for the home office deduction.

The home office tax deduction can be used whether you own or rent your home—this could mean significant tax savings.

“With proper planning, the home office deduction can offer some real tax savings to business owners who work from home,” says Brendan O’Connor, senior attorney with RJS Law Firm, a tax resolution law firm.

“Business owners who work from home have the potential to write off many costs associated with their home that would otherwise be nondeductible,” says O’Connor. “Taking the home office deduction can benefit a business owner’s tax situation.”

The home office tax deduction is beneficial for company owners who conduct part or all of their business from home, adds Cindy Dillard, CEO and partner of Small Business Accounting Tax & Bookkeeping Service.

“The deduction allows you to deduct a portion of expenses you pay to operate your home, such as mortgage interest and taxes, utilities, insurance, internet and phone and repairs,” continues Dillard. “If you have space in your home to designate for business, you can get a tax deduction for something you’re paying for anyways.”

Eligibility Criteria for Home Office Deduction

“In order to be eligible to take the home office deduction, your residential space must either be used regularly and exclusively for conducting business or be the principal place of the business,” says O’Connor.

According to O’Connor, the two key questions business owners should ask themselves are:

1. Do I have a dedicated space in my home for work?
2. Do I perform some or all of my job functions at home?

“If you can answer yes to both of these questions, I’d suggest exploring this deduction further with your CPA or tax professional, because it could mean hundreds and potentially thousands of dollars of tax savings, depending on your tax bracket,” says O’Connor.

Regular and Exclusive Use

In order to qualify for work from home tax deductions, part of your home must be exclusively used to conduct business. For instance, if you have an extra bedroom, you can deduct expenses for that room, providing you only use it for work. (That means your home office can’t also serve as a guest room.)

“There are exceptions to the exclusivity requirement,” says tax attorney Jennifer Correa Riera, a partner with Fuerst Ittleman David & Joseph. “These include if you run a business licensed to provide day care services for children, handicapped individuals or people 65 or older. It also applies when the business’s use of the home is for the storage of inventory or product samples.”

Principal Place of Business

In order to be eligible for the home office tax deduction, the business must have its principal place of business at the home.

“Generally, that means the portion of the home attributable to the business must be used exclusively and regularly to conduct the business’s administrative or management activities, such as keeping the business’s books and records, billing customers or setting up appointments,” says Correa Riera.

You may conduct business at a location outside of your home on occasion, but your home should be your main business location.

Additionally, you can deduct expenses for a free-standing structure that you use exclusively and regularly for your business—like a garage, barn or studio.

Determine a Home Office Tax Deduction Method

There are two ways to apply the home office tax deduction. The IRS refers to these options as the simplified option and the regular method.

Simplified Option

“With the simplified option, entrepreneurs may deduct $5 per square foot for the space used in the home by the business,” says Correa Riera. “This method is limited to a maximum of 300 square feet of space.”

This results in a maximum deduction of $1,500.

As its name suggests, the simplified method is fairly easy to calculate, says Christopher Haas, founder of Haas & Sons Electric. He works from a home office.

“For me, the simplified version works best. It’s much easier to figure out and requires less paperwork to sort through and store,” says Haas. “The write offs have helped me balance my earnings and expense report, therefore paying fewer taxes at the end of the year.”

If you find it difficult to keep records of all the various expenses involved in having a home office, then the simplified option may be your best option, according to Dillard.

“You might miss out on some deductible expenses, but it will save you time figuring out what you can claim and make record-keeping much easier,” she says.

Regular Method

With the standard method, the home office deduction is based on the percentage of your home used for business, which is measured against actual expenditures. This allows you to deduct a portion of your mortgage interest, taxes, utilities, insurance, maintenance and repairs and other expenses.

“Let’s say you have a 1,000-square-foot home and your office is 100 square feet, or 10 percent of the total area,” says Haas. “You could write off 10 percent of your electricity, waste, heat, gas, water, etc.”

“Using the regular method for home office deduction also allows a depreciation deduction for the percentage of the home used for the business’s activities,” says Correa Riera. “It’s important to note, however, that a depreciation deduction may lead to possible capital gains issues when the home is sold or otherwise disposed of.”

The regular method requires that you keep detailed records substantiating the expenses that make up the home office expense deduction, in case of an audit.

“It’s also important to note that the overall home office tax deduction is capped at the income earned from the specific business,” notes O’Connor. “That means the deduction can’t be used to generate a loss.”

FDA Says ‘Rhino’ Male Sexual Enhancement Products May Pose Health Dangers

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The agency has issued a warning to consumers about the unapproved sexual products that are sometimes sold at gas stations.

By Christopher Curley
December 3, 2018

Rolling up to your local corner store and trying out one of their dubious, but inexpensive, male enhancement products might seem like a bit of fun.

But these unregulated supplements pose serious health risks, a recent consumer advisory from the U.S. Food and Drug Administration (FDA) warns.

These products — which are usually marketed under the Rhino brand with names like Krazzy Rhino 25000 and Platinum Rhino 25000 — contain unlisted ingredients that are chemically similar to generic versions of sildenafil (Viagra) and tadalafil (Cialis), along with an unknown array of other hidden compounds.

That can make for dangerous interactions with other prescription drugs, especially since consumers don’t know what drugs are contained in these over-the-counter products, FDA officials said.

“Consumers should… be on alert for products that offer immediate or quick results and that sound too good to be true,” the FDA statement reads. “Use common sense. Claims that sound too good to be true probably are; search for information using noncommercial sites rather than depending on information provided by sellers.”

How these drugs end up on shelves

These male enhancement pills are unregulated, illegal, and dangerous. So how exactly do they end up on gas station and convenience store shelves?

The answer has to do with the distinction between dietary supplements and drugs.

The FDA regulates drugs before they hit store shelves. Dietary supplements are only monitored and reviewed if they’re “adulterated or misbranded” after they come to market, the agency says.

That gives the supplement market a bit of a Wild West character: Anything can happen, and you don’t always know what you’re going to get.

“Based on the large holes that are built in the regulatory regime for dietary supplements, companies feel comfortable making whatever claims they want to until they can’t anymore,” Andrew Ittleman, an FDA compliance attorney at the firm Fuerst Ittleman David & Joseph, told Healthline.

Instead, he says, it’s often up to local law enforcement, municipalities, or states to identify and track dangerous supplements hitting the market.

“In a lot of cases, that information gets to the FDA through those local efforts,” he said.

The appeal of these drugs

Most men probably aren’t expecting sexual miracles from gas station supplements. But the success of these products — 25 of which the FDA identifies under the Rhino name as having suspicious, unlisted ingredients — suggests the appeal is more than mere curiosity.

There are two main reasons, Dr. Don Grant of the U.K.-based online pharmacy The Independent Pharmacy, explains.

“Consumers turn to unlicensed erectile dysfunction (ED) products, like Rhino, primarily due to their low price. Licensed ED products, like Viagra, are often more expensive than their unlicensed counterparts,” Grant told Healthline.

“[But] another reason why unlicensed ED products are so popular is because consumers often don’t need to interact with medical professionals to receive the drugs,” he added.

For many men, the shame factor could make the prospect of an easy transaction at a gas station more appealing than a doctor’s visit.

Then there’s the high cost of healthcare in the United States.

Paying to see a doctor or a specialist if you’re under- or uninsured to get a prescription for Viagra or Cialis might simply be too expensive or onerous. For these consumers, products like Rhino gain extra appeal.

Ill effects are unknown

Another issue with these gray market supplements is that their chemical composition can be changing all the time.

They may “work” for a short time, but not in a directed or safe way, says Dr. David Shusterman, the medical director of urology at NY Urology.

Some of these drugs will increase overall blood flow and blood pressure, which is good for erections, but can also be bad for your brain, heart, and other organs.

“What a urologist would do for you is not give you drugs that are over the counter. He’ll give you drugs that are actually working directly on your penis and do not increase blood pressure and do not increase energy levels but improves just where you need it — which is in your erection,” Shusterman told Healthline.

In short, “nondoctor-prescribed supplements and enhancements should never be used at any time,” he said. “A doctor should always be able to look at the drugs in the supplement to make sure none of the drugs are toxic.”

Staying knowledgeable

In the meantime, consumers can empower themselves by checking any dietary supplements — not just the male enhancement kind — against the FDA’s running list of tainted products.

It’s by no means complete. But the list can help people make a more informed decision.

Independent third-party websites, such as Trustpilot, can also help fill in the gap in vetting online retailers of supplements and medical products.

“The exploitation of legal loopholes by drug manufacturers and illegitimate online prescribing sites is prompting governments around the world to amend regulation procedures. However, it is also down to the consumer to research and educate themselves before purchasing a potentially dangerous product,” Grant said.

“Any ED product that promises impossible results… is probably too good to be true,” he said.

Government bans on pot research have created room for marijuana health hype

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November 06, 2018
By Angela Chen

Research is promising, not definitive, but that hasn’t prevented companies from trying to cash in

For most of her life, Elizabeth avoided marijuana. She came from a conservative family of the “just say no” variety, and her first experience with the drug at a party in her late 20s made her want to curl up into a ball and hide. “The whole world seemed frightening and loud,” she says. “Everyone was sitting around and laughing and having fun, and I was becoming paranoid.”

But Elizabeth (who requested we use a pseudonym) also struggled with anxiety and had a high-pressure job; complications with insurance made it difficult to get Xanax. She started hearing about the anxiety-relieving benefits of marijuana and learned about different strains of the plant, like sativa and indica. Maybe it wasn’t all marijuana that would cause her to panic. If she could find the right strain, maybe that would do the trick.

Elizabeth ended up using a kit from EndoCanna Health, which promises to test your DNA to determine which strains of marijuana might be helpful and which might make you afraid. The idea is that variations in genes can affect how our bodies break down different types of marijuana, and genetic testing can match us with the one that has the fewest side effects. “Our mission is to demystify how cannabis interacts with human DNA,” EndoCanna CEO Len May told me. “We want people to feel much more confidence in the way they include cannabis in their health and wellness regimen.”

May’s team referred me to Elizabeth and, for her, it seemed to work. She had started experimenting on her own anyway, but the report went further, suggesting that she try tinctures and providing optimal ratios. “Taking the test made me feel like I wasn’t just playing roulette with what I was taking,” she says. She feels more relaxed in general and no longer gets paranoid from pot.

Elizabeth is a success story for the industry, but experts in the field say that it’s simply too early to know whether these marijuana genetic tests work. “We’re not really at that point yet,” says Saeed Alzghari, director of clinical pharmacy at Gulfstream Diagnostics. There are only a few trials studying marijuana and genetics and most of them have very few participants. “It’s still not enough to say whether these results are going to be meaningful for practitioners,” adds Alzghari. We certainly don’t know enough to recommend exact ratios.

The 2016 election was a tipping point for marijuana legalization. This year’s midterm elections offered residents of Utah and Missouri the chance to legalize medical marijuana in their states. As marijuana legalization spreads, more and more companies will be like EndoCanna: based on some science but with claims that stretch beyond the conclusions of established research.

Once, marijuana was the target of Reefer Madness panic, even though there’s no evidence that it’s caused a single death. Politicians like Attorney General Jeff “good people don’t smoke marijuana” Sessions are still stuck in this narrative, so it’s little wonder that people are pushing back. As a result, we have cannabidiol (CBD) in everything, even though we’re not sure if it’s doing much. One cannabis dispensary will soon offer “luxury products.” Another company claims it’s “one of the first to bring AI, machine learning and the ‘Internet of Things’ to the cannabis market.” The “largest cannabis dispensary superstore/entertainment complex in Vegas” just opened. All the while, the research lags behind. It’s hard to study marijuana, and there’s money to be made in the business. That’s an unfortunate combination that makes it exceedingly hard to separate the truth from the hype.

States that have legalized medical marijuana draw upon a growing body of research. Studies have investigated whether marijuana can be helpful for conditions from nausea to pain to Parkinson’s disease and inflammatory bowel disease. Some results are encouraging, but in many cases, the evidence for health benefits is either not very strong or is quite limited.

Marijuana is frequently touted as a treatment for chronic pain and PTSD, but that claim is questionable, according to a study published in Annals of Internal Medicine last year. The authors note that between 45 and 85 percent of people who use medical marijuana want to manage their pain, but an analysis of 27 studies doesn’t support that cannabis is really helping. When it comes to PTSD, there was too little conclusive data. A different study from the Journal of the American Medical Association found high-quality evidence that marijuana can help conditions like multiple sclerosis — but acknowledged that the drug is also used in many cases where the evidence is insufficient.

There are a lot of problems with the methodology of cannabis research, says Sachin Patel, a cannabis researcher at Vanderbilt University who was not involved in the study. (The study authors work with the Veterans Health Administration, which limits their ability to give interviews on this topic.) For example, many studies only look at participants who self-report using cannabis, which provides much weaker evidence than randomly assigning a group of participants to take either a cannabis product or a placebo. Additionally, many studies only look at the short-term evidence which, of course, won’t tell us much about chronic conditions. It’s not that we know cannabis isn’t helpful for issues such as PTSD or chronic pain, Patel adds. It’s simply that existing research doesn’t provide strong evidence that it does. Research is promising, not definitive.

In short, the public perception of marijuana benefits and risks doesn’t align with the data, according to a study from this September, also published in Annals of Internal Medicine. “Absence of evidence is not evidence of absence, but if something is being marketed as having health benefits, it needs to be proven to have health benefits,” says Salomeh Keyhani, a professor of internal medicine at UC San Francisco and an author of the study. “I think it’s very dangerous to be asserting that things are very beneficial without thinking about risks.” For example, 66 percent of the 16,000 Americans surveyed do believe that marijuana has big benefits for pain, and 9 percent of Americans believe marijuana has no risks. Nearly 30 percent believe that smoking marijuana prevents health problems. And 22 percent of Americans surveyed believe that marijuana is not at all addictive, which is not true.

Roughly 10 percent of people who start smoking marijuana become addicted, says John Kelly, a Harvard University psychiatry professor who studies addiction. That means that they’ll experience withdrawal symptoms like irritability or cognitive fogginess and behave compulsively to make sure they have access to the drug. “I don’t think anyone in the clinical realm has any doubt that it’s a psychoactive drug that can cause addiction,” says Kelly, “ and marijuana addiction is growing.” Young people, especially, are more likely to become addicted, and Kelly thinks that the growing potency of cannabis may be making things worse. None of this is to say that marijuana addiction is worse than being addicted to any other drug, and Keyhani points out that there are methodological problems with research on the harms of cannabis, too. Marijuana comes with both benefits and risks and there’s a lot we don’t know.

Marijuana is never just marijuana. More than any other drug, it has been linked to politics, from xenophobic attitudes to the injustice of mass incarceration. The way that marijuana has always been a lightning rod for activism can make it hard to see beyond the symbolism. Our government isn’t making it easier.

For the past 50 years, the Drug Enforcement Administration (DEA) has classified marijuana as a Schedule I drug alongside heroin, LSD, and cocaine — meaning it is considered to have “no currently accepted medical use and a high potential for abuse.” As one example, scientists who want to study the substance must use federally approved samples, which aren’t as potent as the offerings readily available to consumers. Though the agency has repeatedly refused to reschedule marijuana, two years ago, it did promise to give licenses to more universities to do marijuana research. However, Stat has reported that the DEA did not grant these additional licenses and has stopped accepting applications for them, impeding progress again.

The irony is that by trying to keep us “safe” and refusing to reschedule, the DEA is making us less safe by letting us be drowned by hype without quality evidence either way. When it comes to research, many of the methodology problems that Patel points out are the result of government roadblocks.

One way around the bureaucracy is to go through a different type of bureaucracy. Earlier this year, the US Food and Drug Administration (FDA) approved GW Pharmaceuticals’ Epidiolex, a drug that contains CBD and treats severe childhood epilepsy. As a result, the DEA rescheduled Epidiolex specifically — though not CBD or cannabis in general — to low-risk Schedule V. With the move, the DEA is showing a “fair amount of deference” to the FDA, Andrew Ittleman, a partner of the law firm Fuerst Ittleman David & Joseph, told The Verge. “The DEA is saying, ‘If you’ve satisfied FDA, you’ve satisfied us.’”

Still, gaining FDA approval is a lengthy and expensive process, and not everyone who wants their product to be legal cares about medical approval. And though the regulatory dam is starting to crack, the rescheduling of cannabis doesn’t look like it’s anywhere on the horizon. This is a dangerous place to be. There are lobbyists on both sides and plenty of money pouring in, but until it becomes easier to study marijuana and conduct high-quality research, it’s hard for the public to know what’s best.

This cannabis-derived drug just got approved, but that won’t make it easier to get edibles

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October 03, 2018
By Angela Chen

Once again, the government says it’s okay to get cannabis from your doctor, but not over the counter

Last week, the Drug Enforcement Agency gave the all-clear for Epidiolex, an epilepsy drug derived from cannabis, to be sold on the market. Though cannabis is still illegal at the national level, Epidiolex is now in the least restrictive category of drug regulation, Schedule V. The move is a good news for pharmaceutical companies that want to develop their own cannabis-based drugs, but it won’t mean much for other cannabis “wellness” products.

Epidiolex, made by GW Pharmaceuticals, treats severe forms of childhood epilepsy and is the first drug derived from natural cannabis that is approved by the US Food and Drug Administration. Epidiolex includes cannabidiol (CBD), a chemical that comes from the cannabis plant that is not psychoactive. (In terms of legality, no one really knows how to classify it yet.)
Though the FDA approved the drug back in April, GW couldn’t sell it because the DEA has deemed cannabis a Schedule I drug along with heroin, LSD, and cocaine, meaning it is considered to have “no currently accepted medical use and a high potential for abuse.” Now, Epidiolex specifically — but not CBD or cannabis in general — is Schedule V. “The DEA is saying, ‘if you’ve satisfied FDA, you’ve satisfied us,’” says Andrew Ittleman, a partner of the law firm Fuerst Ittleman David & Joseph. It’s showing a “fair amount of deference” to the FDA.

In other words: CBD in an FDA-approved product is okay and has a low potential for abuse, and CBD in a product not approved by the FDA is as dangerous as heroin. (Sorry about your CBD lattes.)

Schedule V includes the other anti-seizure drugs, so it makes sense that the DEA made this choice, says Stephanie Yip, an analyst with Informa Pharma Intelligence. For context, other cannabis-based drugs on the market (these are synthetic, whereas Epidiolex is natural) are in Schedules II and III because they contain the psychoactive component THC. Yip adds that, in the past four years, the number of companies doing cannabis research has grown from 16 to 40; these are mostly smaller companies, not including partnerships. The main research interest is pain and then chemotherapy-induced nausea and vomiting.

So expect pharmaceutical companies to take note. But this won’t have much of an effect on the CBD wellness products — including mascara, bath bombs, and weed lube — that are popping up everywhere. “I don’t believe there is a practical application for a cannabis manufacturer,” says Serge Chistov, an investor in Honest Marijuana Company. The government might be softening its grip, but the decision is so limited that “it really doesn’t help us unless we want to go the FDA route.”
And the FDA route is bureaucratic and expensive. Because cannabis remains Schedule I, it’s difficult for scientists, both in academia or industry, to do research on the drug. Daniel Friedman, an NYU neurologist who co-authored a study investigating the effectiveness of Epidiolex, told The Verge that the team had to go through a complicated bureaucratic process. This involved obtaining a special license from the DEA, special equipment, and “all that infrastructure makes it prohibitive to do studies in other conditions by people who may want to do so, but don’t have the resources.” These same restrictions mean that as of 2013, fewer than 20 randomized controlled trials (the gold standard for scientific research) have tested the benefits of marijuana, according to the American Medical Association.

That leaves many manufacturers bypassing the FDA entirely. Most CBD products are not exactly legal, and there are plenty of gray areas as individual states decide what to do. In fact, the FDA has sent “warning letters” to CBD manufacturers before, though with giant corporations like Coca-Cola considering CBD drinks, there’s unlikely to be a real crackdown.

We have ended up in a labyrinth of contradictory rules: it is extremely difficult to obtain the license to study cannabis, a dangerous drug. But if you do study it and it gets approved, the cannabis is not dangerous anymore. It’s good that Epidiolex has been moved to Schedule V, but this narrow move won’t solve these two larger and interconnected problems. It’s too hard to study cannabis, full stop. And precisely because it’s so difficult to study, there’s a lot of hype and misinformation, which makes it easy for people to shill CBD and cannabis products that might not live up to their promises. This quasi-legal industry remains unregulated and potentially full of snake oil salesmen. Last year, the FDA tested CBD wellness products, and many didn’t contain the amount they had claimed.

Ittleman doesn’t believe that the DEA will reschedule cannabis anytime soon because the administration is strongly against legalization. (Don’t forget: Attorney General Jeff Sessions has publicly stated that “good people don’t smoke marijuana.”) Ittleman is probably right, but the DEA’s decision regarding Epidiolex is still a move forward. However, it’s not enough to reschedule a single drug and expect that to dramatically change the landscape. Our other issues remain, and they will until we accept once and for all that cannabis is hardly the same as heroin.

Feds Look to Seize Porsche Tower Condo Unit Tied to $1B Money Laundering Case

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August 7, 2018
By Keith Larson

Prosecutors allege the $5M unit was used as compensation for illegal services

Federal officials are seeking to seize a condo unit at Porsche Design Tower in Sunny Isles Beach that they allege is tied to a $1 billion Venezuelan money laundering scheme.

Prosecutors allege the scheme laundered money out of Venezuela’s state-run oil company, PDVSA, and into fraudulent investments and Miami real estate. One deal allegedly involved was the $5.3 million purchase of unit 2205 at Porsche Design, a 132-unit, 60-story luxury condo tower built by Dezer Development.

Federal officials are now seeking to seize the unit and recently filed a notice of lis pendens in the U.S. District Court for the Southern District of Florida. Andrew Ittleman, a partner at Fuerst Ittleman David & Joseph who focuses on white collar defense and money laundering, said filing a notice of lis pendens makes the property “impossible to sell until the resolution of the case.”

Paladium Real Estate Group LLC purchased the unit from the developer in January 2017, according to property records. State records show that the wife of the Venezuelan Ministry of Oil and Mining’s former legal counsel originally managed the LLC. Juris Magister, a Brickell law firm, is the registered agent.

In the initial indictment, federal prosecutors allege the former legal counsel, Carmelo Urdaneta Aqui, discussed transferring the unit to an alleged Venezuelan money launderer, Jose Vincente Amparan Croquer, as compensation for his services. Amparan’s wife was added as a manager of the buyer’s LLC in September 2016. A year later, Urdaneta’s wife was removed, “leaving Amparan in control of Paladium and the condominium,” according to the indictment.

Conspirators in the alleged scheme include former PDVSA officials and members of the Venezuelan elite, also known as “boliburgués.” Shortly after the indictment was filed in late July, the Miami Herald reported that Venezuela President Nicolás Maduro is under investigation by the U.S. government for his role in the alleged scheme.

The U.S. Attorney’s office declined to comment, citing pending litigation.

Ittleman said that when the federal government looks to seize an asset in a money laundering case, it is usually successful.

Dezer completed the beachfront tower in November 2016, and a number of owners have tried to flip their units since then. The building is known for its “Dezervator,” a patented car elevator that takes residents up to their units in their cars.

Dezer Development did not immediately return a request for comment.

Russia Sanctions Bill Also Targets Real Estate Deals

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August 3, 2018
By Samuel Rubenfeld

Provision would make title insurers reveal owners, broadening a law that exists in some cities

New sanctions on Russia proposed by a group of U.S. senators also includes a provision that would make title insurance companies reveal the owners of shell companies when they make all-cash real-estate purchases anywhere in the U.S.

Shell-company real estate deals are legal, but are attractive to money launderers because the purchase can be made anonymously and the buyer doesn’t have to explain the origin of the funds used. Analysts say that secrecy has allowed kleptocrats, human traffickers and other criminals to exploit a hole in the U.S. financial system to legitimize their funds.

Law enforcement has seized property, ranging from Manhattan apartments to California mansions, in its pursuit of money laundering by corrupt foreign officials stashing their funds in the U.S. as part of its Kleptocracy Asset Recovery Initiative.

A requirement on title-insurance companies to disclose shell-company ownership already exists, but only in certain cities, such as New York City and Miami, and on deals above a specific value threshold. That program, known as a geographic targeting order and subject to a renewal every six months, began in 2016, following years of reporting by media organizations on the secrecy of real-estate transactions.

A push to bring the effort national began this week. Sen. Marco Rubio (R., Fla.) on Monday proposed an amendment, separate from the Russia package, that would give Treasury 180 days to provide Congress details about the data it has collected thus far, with an aim toward nationalizing the program.

The proposal on Thursday from the bipartisan group of senators is part of a laundry list of “crushing” sanctions measures targeting Russia. “The sanctions and other measures contained in this bill are the most hard-hitting ever imposed—and a direct result of [Russia President Vladimir] Putin’s continued desire to undermine American democracy,” said Sen. Lindsey Graham, (R., S.C.).

Earlier this year, the Treasury delivered a report to Congress about the potential exposure of key U.S. economic sectors, including real estate, to Russians connected to President Vladimir Putin. The full report hasn’t been made public.

The proposal announced Thursday also follows a separate push from states and federal officials to advance corporate transparency by pushing for legislation that would require shell companies to disclose their owners.

After the program involving title-insurance firms went into effect in 2016, all- cash purchases by companies dropped nationally by about 70%, even in areas not subject to the requirements, according to a working paper from economists at the Federal Reserve Bank of New York and the University of Miami. The study found a 95% drop in the cash spent by shell companies and other corporate entities on homes in Miami alone.

Buyers will still come up with another way to purchase the real estate, such as through a straw buyer or a third party, said Andrew Ittleman, a partner at the firm Fuerst, Ittleman, David & Joseph LLP whose practice focuses on anti- money-laundering compliance.

“The government will come up with a law-enforcement tool and the people impacted by it will find a way around it. And we’ll have a new discussion in about five or 10 years,” said Mr. Ittleman.

When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon?

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May 22, 2018
By The Niche

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? Or will things heat up further?

In the interview I did last week with Patti Zettler she mentioned the possibility of a voluntary stop by the clinics. The more I think about it and read other things out there including a helpful piece on this situation by attorney Richard Jaffe, it seems like this is the most immediate question today related to this situation. Jaffe’s piece paints a pretty difficult picture for USRM and CSCTC/CSN. It seems like the companies are stuck between a rock and a hard place. So, what are they going to do?

Jaffe discusses potential factors for the two firms in favor and against shutting down the stem cell offerings, starting with those in favor of the firms stopping: “The FDA can seek a preliminary injunction barring treatment pending the outcome of the case” and “Potential criminal prosecution.” Keep in mind this is somewhat hypothetical at this point, as to the latter possibility, Jaffe lays out how this might unfold and possibly even end up in what he calls “Felony Land”. He writes that the felony possibility would hinge in large part on intent and he continues:

“Based on the operators’ prior receipt of the warning letters in late summer 2017, and more importantly, the fact that the operators are now being charged with FDA violations in a civil action, well that goes a long way towards proving they had intent or knowledge that what they are doing is illegal.”

If Jaffe’s right, that’s a big risk for USRM and CSCTC/CSN to take on if they opt not to cease doing what the FDA wants them to stop. Of course, Jaffe could be wrong. We’ll see soon how it plays out. One point of clarification on the above Jaffe quote is that to my knowledge based at least on what’s in the public domain, CSCTC/CSN has not yet received an actual warning letter, although the 483s on their inspections were notable.

Jaffe also mentions the relevance of the past USA vs. Regenerative Sciences case:

“…when the FDA filed a permanent injunction action against Regenerative Sciences and its physician owner, Chris Centeno, he decided to stop treating patients with his expanded cell, stem cell procedure pending the outcome of the case. Turned out he made the right decision since he lost both at the district and appellate court levels. I suspect that no criminal charges were brought against him in no small part because of that decision.”

I asked attorney Andrew S. Ittleman, who was counsel for Regenerative Sciences in the case, for his take on Jaffe’s point and about the relevance of the USA vs. Regenerative Sciences to the new suits:

“Regarding the Regenerative Sciences case, there was never a risk of criminal prosecution. Keep in mind that that case started more than 10 years ago, and at that time there was virtually none of the authority we have today defining the scope of FDA’s jurisdiction or the meaning of the terms in the Part 1271 regulations. That case is still instructive though, mainly because it reveals how unwilling the courts can be to wade into a technical dispute between a federal agency and a regulated business. Keep in mind that the government’s motion for summary judgment was granted and Regenerative’s counterclaims were dismissed before discovery even began! In matters like these, where the case is based on concepts which have been delegated by Congress to FDA and which the government describes as impacting the public health, expect the courts to defer to the agency and keep the litigation brief.”

Getting back to Jaffe, he goes on to list those factors he feels might favor the firms not choosing to shut down stem cell offerings at this point:

“Factors weighing for not closing down pending the end of the case:

1. There’s been no decision by a judge yet, and everyone is entitled to present a defense.

2. Their case is different from Chris Centeno’s case in the following ways: ____________,_______,______ (the defendants will have to fill in the blanks.

3. These folks are very, very motivated to seek vindication. Both Berman and Comella have been quoted in the stem cell press as expressing a high degree of motivation and belief in the righteousness of their actions, and caving-in just might not be in their DNA.

4. And here is the biggest factor and the consideration which could carry the day if they decide not to close down pending the outcome of the case:

Both operators have networks of physicians or franchisee physicians providing stem cell treatments throughout the country. (And that’s a big part of the reason why the FDA chose to go after these two first)….One way or the other, there might be some collateral legal/liability issues between the operators and their networkees.“

With all of this in mind, what happens next?

Jaffe has an overall prediction, “Having defended medical mavericks for a long time, my guess is that at least one of them (and probably both) is going to stay open, but we’ll see. It would be hard to overestimate the impact of these cases as they wind their way through the courts.”

Jaffe didn’t mention the additional possible considerations for USRM in deciding what to do based on the fact that it is a publicly-traded firm, which makes a big difference. Jaffe also could have mentioned that USRM itself disclosed it was subpoenaed by the SEC recently, which doesn’t exactly help lower the pressure on the firm.

Will one or both of these firms (including potentially CSN’s entire network of clinics) decide to stop taking customers perhaps even as early as in the coming week? The fact that we are even discussing this as a possibility shows just how different the stem cell clinic arena is today than it was just a week or two ago prior to the new FDA suits.

Las razones para desconfiar de los tratamientos milagrosos con células madre

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May 20, 2018
By Natalia Martin Cantero

Uno de los campos científicos más prometedores, el de la investigación con
células madre, es también terreno abonado para los timos. Cientos de empresas prometen tratamientos contra todo tipo de enfermedades que no cuentan con el visto bueno de la FDA.

Doris Tyler es una mujer de Florida que quedó ciega tras someterse a un procedimiento con células madre no aprobado por la FDA.

Las falsas promesas sobre los tratamientos de células madre pueden tener consecuencias mucho más graves que despojar al paciente de su dinero. En el episodio más reciente de su cruzada contra las clínicas que ofertan tratamientos a partir de esas células, la Administración de Alimentos y Medicamentos (FDA) emprenderá acciones legales para impedir la actividad de dos de los centros más prominentes del país: el US Stem Cell con sede en Sunrise, Florida, y el California Stem Cell Treatment Center, con sedes en Beverly Hills y Rancho Mirage.

Los tratamientos que ofrecen estas clínicas –desde curas al cáncer a enfermedades del corazón– podrían suponer un riesgo para la salud, según la FDA.

Una investigación publicada recientemente sobre 368 webs de centros que ofrecen combinaciones de tratamientos con células madre con “medicina alternativa y complementaria” reveló que solamente el 31% de los sitios menciona si la intervención cuenta con el visto bueno de las autoridades sanitarias.

Solo un 19% de los sitios especifica que hay pruebas limitadas de la validez intervención, y únicamente el 25% menciona los riesgos generales de la investigación. El imperio en expansión de estas clínicas promete curas para todo. Desde diabetes a asma, esclerosis múltiple, artritis o incluso una vacuna contra el cáncer.

“Muchas clínicas parecen estar basándose en pseudociencia, lo que puede ofuscar seriamente el discurso público, engañar a la población y dificultar el discernimiento entre la ciencia real y la mercadotecnia”, concluye el estudio. “La publicidad sobre terapias con células madre no probadas tiene el potencial de dañar a los pacientes y a la reputación de la ciencia”, añade.

¿Qué son las células madre?
Las células madre son un tipo particular de célula que se encuentra en el cuerpo humano (como en cualquier otro organismo pluricelular) sobre todo en la sangre y en la médula espinal. Su función es regenerar órganos y otras células a medida que envejecemos, y son fundamentales a la hora de ayudar al cuerpo a recuperarse de lesiones. Hay varios tipos de células madre, con diferentes características. Las que proceden de embriones humanos pueden convertirse en cualquier tipo de célula, y en teoría reparar cualquier órgano o tejido en el cuerpo humano. Por el contrario, las células madre “adultas” por
así decir solo pueden convertirse en el tipo de tejido del que proceden, según explica a Univisión Noticias Morton Tavel, profesor de medicina retirado de la Universidad de Indiana y autor de un libro sobre mitos y bulos en salud.

¿Cuáles son los usos probados con las terapias con células madre?
Morton señala que, mientras que el acceso a las células de embriones está regulado por las autoridades federales, la extracción de las otras células madre (las que proceden del cuerpo del propio paciente) está mucho menos reglada. Por esta razón, se han usado de manera indiscriminada. “De hecho, los tratamientos con células madre están ampliamente aceptados solo para dos situaciones: dolencias relacionadas con la sangre –incluidas leucemia y algunas formas de anemia– y en ciertos tipos de lesiones por quemaduras”, señala. En el futuro, cree Morton, la regulación en torno a las células madre podría ser similar a la que existe con los medicamentos con receta.

Morton indica que incluso clínicas muy reconocidas han sido acusadas de
exagerar sus promesas en algún momento. Por eso, antes de que consideres exponerte a un tratamiento con células madre de cualquier tipo es fundamental informarse todo lo que sea posible, preferiblemente con un experto en este campo con licencia médica, recomienda el profesor.

Por otro lado, los tratamientos experimentales con células madre han resultado prometedores en muchos campos, como osteoporosis o lesiones deportivas, y la FDA está evaluando su aprobación.

Florida es uno de los destinos predilectos de pacientes desesperados en la búsqueda de tratamientos que no han sido aprobados. El Dr. Burton Feinerman, en la imagen, es un pediatra que ha ofrecido terapias con células madre en varias clínicas de Florida durante la última década, cuya efectividad ha sido puesta en duda.

¿Qué enfermedades podrían curarse o prevenirse en el futuro utilizando estas terapias?

Ira Pastor, presidente de una firma de medicina regenerativa, señala que las terapias serán de gran utilidad en patologías en las que se producen dinámicas de degeneración celular, como el Alzheimer o el Parkinson.

La degeneración macular por envejecimiento (el trastorno ocular) es uno de los objetivos más prometedores. Todavía falta mucho tiempo, no obstante, para que podamos disponer de tratamientos seguros y efectivos para estos problemas. Una de las clínicas intervenidas esta semana por la FDA está acusada de dejar ciegos a varios clientes con tratamientos para aliviar la degeneración macular.

¿Qué señales deben hacerte sospechar?
El abogado experto en legislación relacionada con alimentos y medicamentos Andrew Ittleman señala a Univision Noticias que hay que sospechar de las clínicas que ofrecen procedimientos no aprobados procedentes de fuentes que no son el paciente mismo, como la membrana amniótica o el cordón umbilical. Muchos de estos tratamientos, señala Ittleman, se ofertan a ancianos y se venden como poco menos que milagrosos. Sin embargo, “muchas investigaciones muestran que no contienen células madre en absoluto. Este es un problema creciente, y un estado (Dakota del norte) ya lo está investigando. Mi expectativa es que otros estados hagan lo mismo”.

Pastor, por su parte, recomienda estar alerta con esas “clínicas que aseguran curarlo todo”, de forma indiscriminada, con células madre.

¿Qué riesgos representan las clínicas que utilizan tratamientos no aprobados para los pacientes?
Ittleman indica que los riesgos son los mismos que con clínicas de otro tipo: los pacientes pueden resultar lesionados, o recibir tratamientos que no funcionan. “Dada la proliferación de practicantes que no son médicos ofreciendo terapias con células madre en sus consultas, estos riesgos pueden estar más concentrados” con este tipo de tratamientos. Pastor alude a problemas financieros: “los pacientes perderán un montón de dinero”, apunta.

¿Debería involucrarse más el gobierno con las pruebas clínicas?
La FDA está implicada en la regulación de las pruebas clínicas y está haciendo
un gran trabajo asegurándose de que los productos que aprueba son seguros y efectivos, señala Ittleman. “Desafortunadamente, en el entorno de las células madre, la línea que separa los procedimientos médicos de la fabricación de productos puede ser muy tenue”. Esto significa que mientras que los médicos saben cómo llevar a cabo un estudio diseñado para mejorar un procedimiento médico, muchos saben muy poco sobre cómo regula la FDA las pruebas clínicas.