3 posts tagged “health laws”

Cannabidiol (CBD) oil and product FAQs: Fad or effective? Legal or not?

Posted May 29th, 2018 by

Trending: Cannabidiol (CBD) oil, gummies, tinctures and more. Why are cannabis products gaining popularity as medical treatments and in general? As more states have legalized medical marijuana, more people have shifted their views on cannabis treatments (like former Speaker of the House John Boehner’s recent change of heart). And last month, an advisory panel at the U.S. Food and Drug Administration (FDA) unanimously recommended a medication made from CBD for some forms of epilepsy.

CBD comes from cannabis/marijuana but has some key differences. So, let’s take a closer look at CBD products and some FAQs, like, do they work and are they legal?

What is CBD?

Short answer: Cannabidiol (pronounced canna-bid-EYE-ol) or CBD is a chemical found in cannabis plants that does not produce a “high.”

More info: Cannabis plants can produce more than 100 different types of cannabinoids, a type of chemical that reacts with receptors in the brain. The two most common cannabinoids found in medical marijuana are THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). THC is responsible for producing the mental and physical effects of medical marijuana. CBD has many of the same therapeutic qualities as THC, but without psychoactive effects. (For even more info, read our report called “Weed 101: How and why patients use medical marijuana.”)

Products made purely from CBD (without THC) do not produce the psychoactive high of other medical marijuana or some CBD/THC combination products. But, as a JAMA report and some in the medical cannabis industry have pointed out, many CBD products sold online are not accurately labeled (containing much more or less CBD than the label claims, or even containing some THC when it’s not mentioned on the label).

CBD is not regulated or approved by the FDA — but they have issued warning letters to some CBD producers with misleading labels.

Many doctors (in the U.S. and internationally) are hesitant to recommend smoking cannabis or inhaling any burned plant material but may be more open to CBD products that are not smoked. (Has your doctor or provider weighed in about medical cannabis or CBD products? Make a comment below.)

Are CBD products effective?

On PatientsLikeMe, members have reported trying CBD for about 160 different reasons, including specific conditions (ALS, Parkinson’s disease, epilepsy and fibromyalgia — to name a few) and symptoms (from anxious or depressed mood to stiffness/spasticity). Below is a list of CBD or cannabis products members have reported as treatments on the site — remember to discuss your treatments with your healthcare provider, and keep in mind that treatment responses vary:

Join PatientsLikeMe to see more details through the links above and to connect with other members about their treatment experiences.

Note: CBD industry insiders advise avoiding splashy websites that offer a “free trial” of the product — by filling out a form, you may be signing up for an unwanted subscription.

Is CBD legal?

Short answer: CBD is legal under some state laws but not under federal law — so it’s pretty confusing (even to healthcare providers).

More info: As of May 2018, there are 17 states with laws specifically about legal CBD. Most state laws allowing some CBD use tend to be very specific (for example, limiting a CBD product’s THC content) and are not the same as state medical marijuana laws.

Under federal law, cannabis products (including CBD) are illegal and classified the same as marijuana (and heroin and ecstasy) as a Schedule I controlled substance. The U.S. Drug Enforcement Agency (DEA) made headlines in Indiana (where some CBD is legal) a few months back when DEA spokesman Rusty Payne told the local news that CBD is illegal under federal law, but is not the DEA’s main focus. “We are in the middle of an opioid crisis in this country,” Payne said. “That’s our biggest priority right now. People are not dying from CBD. Some would argue lives are being saved by CBD. Are we going to get in the middle of that? Probably not.”

Last year, U.S. Rep. Morgan Griffith introduced a bill called the “Compassionate Access Act” to encourage the federal government to remove marijuana from “Schedule I” classification, exclude CBD from the definition of marijuana in order to allow better medical access, and regulate CBD products to ensure they’re low in THC. So far, the bill has only bounced around to various congressional subcommittees.

Have any questions, comments or feedback on CBD products? Make a comment below or — even better — become a PatientsLikeMe member to discuss this topic in the forum and see more treatment evaluations from people living with your condition.

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What’s the right-to-try bill + possible pros and cons?

Posted March 30th, 2018 by

The U.S. House of Representatives recently passed legislation that could give terminally ill patients the “right to try” experimental treatments — so what’s the controversy? Catch up on the topic and share your thoughts below.

“Right-to-try,” in a nutshell

The “right-to-try” bill aims to give terminally ill patients who’ve exhausted all other treatment options quicker and easier access to an “experimental treatment” (this is a medication or treatment product that has passed “phase one” of the clinical trial process but has not yet received full Food and Drug Administration [FDA] approval). See this PatientsLikeMe guide to clinical trials to learn more about trial phases and the FDA drug approval process.

The House failed to pass the bill on the first try, on March 13, but voted 267 to 149 to pass it on March 21.

All in favor…

Backers of the bill have cited these “pros” in their reasoning:

  • 38 states have already passed their own versions of “right-to-try” legislation, so a federal version of the law would grant access to experimental treatments nationwide.
  • Although the FDA has existing “expanded access” (or “compassionate use”) policies that allow the use of investigational treatments in the most dire cases, patients must apply to the FDA for permission to receive the treatment — so “right-to-try” would eliminate the step of needing to apply.
  • Most terminally ill patients don’t qualify to participate in clinical trials, so “right-to-try” could give them quick access to treatments that are still in the middle of years-long trials.

All opposed…

People who are against the bill have some arguments of their own:

  • Four former FDA commissioners issued a joint statement opposing the federal “right-to-try” legislation, saying it would “create a dangerous precedent that would erode protections for vulnerable patients.” (When the FDA is involved in “expanded care” cases, it tries to provide any additional information on dosages, side effects and safety considerations — so removing the FDA from the process may eliminate expert guidance and safeguards.)
  • Many drugs that make it through phase I of clinical trials (smaller initial studies to test for safety) fail to survive phase II of trials because they’re not proven to be effective — so “right-to-try” may open the door to developers peddling “snake oil” or hyped-up/unproven treatments to the most desperate patients.
  • “Right-to-try” may not significantly expand access to treatments — the FDA says it grants approval in 99 percent of requests through the “expanded access” policies and often authorizes emergency requests immediately over the phone. And few pharmaceutical companies offer access to experimental treatments without FDA approval because of ethical and legal concerns.

“No ethical company that I know of would make their experimental medicine available outside of the FDA’s regulatory oversight process,” Kenneth Moch, CEO of drug developer Cognition Therapeutics, tells the Associated Press. “The FDA are not the bad guys here. You may not like their processes but they are involved here for a variety of reasons.”

Modern Healthcare points out that using an experimental treatment can derail a patient’s health insurance coverage for additional medical treatment or hospice care thereafter.

“If the bill is passed and signed, the campaign that made it law may not stop there,” Modern Healthcare also reports. “Some believe there is a chance the program’s scope could be expanded beyond terminally-ill patients to one day include those with severe chronic conditions.”

Next up, the “right-to-try” bill heads to the Senate. If they pass it, the president (who has expressed support) is expected to sign it into law.

What are your thoughts on the “right-to-try” bill? Join PatientsLikeMe to talk about this topic with a community of other real-world patients.

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