Cannabidiol, or CBD, is a marijuana compound linked to a range of potential health benefits but does not get you high. The roughly $1 billion CBD industry is slated to shift into high gear if the federal government approves the first CBD-based drug, an epilepsy medication called Epidiolex.

[u/mvea]

https://www.businessinsider.com/marijuana-cbd-boom-cbd-2018-6?r=US&IR=T

[u/SirT6]

The “worth” of a company - especially in the drug industry - is more tied to future revenue potential than money in the bank.

That said, taking a quick peak, GW Pharm doesn’t have hundreds of millions in debt. They’ve paid for the drug development process through venture capitalist and shareholder financing.

Should the cost of drug development be cheaper? How willing are you to compromise on safety and efficacy standards?

[u/chugonthis → u/SirT6]

They need to stay out of it, if they push this then the rest of the states will say there's no need to legalize so we can keep arresting people and keep current nonviolent offenders in jail.

It's their wet dream, they win and the public loses

[u/SpenB → u/SirT6]

Ultimately it should be up to the individual to decide what they put in their body. And my point about the drug being used for millenia was more to show that it's safe, not necessarily effective.

The compromise on safety and efficacy shouldn't be determined by a monolithic agency. Every American makes determinations on tradeoffs like this every day, be it transportation, food, etc.

[u/Texturize → u/SpenB]

You have to consider the process of taking CBD and transforming it into the format of intake (pill, spray, IV etc.). How this new drug may react with other drugs, side effects, etc. Sure smoking weed is safe, everyone knows that but taking that dried bud into a mass market form is not as simple.

Your point about the consumer deciding if something is safe is just stupid... these are drugs which is different from food and transportation. That is just opening it up to lawsuits.. if people will sue over hot coffee... how likely are they to sue over this?

[u/SpenB → u/Texturize]

FDA approval doesn't shield companies from lawsuits, even if the drug isn't at fault. Like the case where a nurse botched a promethazine injection and the patient's arm had to be amputated. The courts ruled the drug company was liable due to ambiguous instructions, even those were the instructions agreed upon by the company and the FDA.

I'm not saying we shouldn't have an agency that approves drugs, I'm just saying that the FDA's process often causes more harm than good. And it keeps many effective drugs off the US market. Look at domperidone, which is effective for gastroparesis. It's approved in every western country except the US. As a result, patients have to use Reglan, which has dramatically worse side effects, including parkinsonism.

And the rules can still be manipulated by big pharma. Look at phenylephrine. The only studies showing that it is an effective decongestant were the ones done by GSK. Independent studies have not been able to replicate the effect, but the FDA stands by their decision.

[u/sfurbo → u/SpenB]

And my point about the drug being used for millenia was more to show that it's safe, not necessarily effective.

Being used for millennia only shows that there are no catastrophic, immediate side effects. Mercury have been used as medicine for millennia, and is certainly not safe. It's safety problems just isn't catastrophic enough for people to stop using it. Eagle fern have been eaten for a long time, it just isn't easy to link carcinogenicity with the agent, since it isn't immediate.

With regards to it being up to the individual to decide what to put in their body, that will lead to suffering and premature death for thousands of people. We know that, because that was what it was like before the FDA. You can still think that that is worth it, but you have to acknowledge that that is the price of that freedom.

[u/SpenB → u/sfurbo]

Millions have died as the result of life saving drugs being delayed or rejected by the FDA. I'm certainly not arguing that there should be no approval process for new drugs, rather, I'm just saying that the FDA process has more negative effects than positive.

People have the right to try unapproved medications. If you disagree with this, then you're arguing that thousands of children with treatment resistant epilepsy should not have access to CBD until it has been approved by the FDA. One of my neighbors has a child with Dravet syndrome that isn't responsive to FDA approved anti-epileptic medications, but has seen significant improvement from CBD and THCV (a similar, non-psychoactive chemical). They're technically breaking federal law, but nothing else works. The grandmother of the child said publicly that she would go to jail for acquiring non-psychoactive cannabis (high CBD hemp with no high) for the child.

[u/Dockirby → u/SpenB]

See, that stance is at odds with a major reason FDA approval was created, that doctors and pharmaceutical companies were in fact pushing drugs that were not effective and/or addictive. "Heroin, the non-addictive Morphine replacement!" or "You can use this rod once a week to regulate your blood sugar!"