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Comment by wincy | Hacker News Reader

Hi Alex, do you have any plans on selling or attempting to get FDA approval for drugs that are used and known to be safe in other countries, such as the UK?

Our daughter has a life threatening condition that I’ve posted a lot about on, a complication from spina bifida where she holds her breath when she gets upset. Many kids die from the condition.

There’s a medication, piracetam, that a child with the same complication uses in the UK. It’s safe and has greatly helped the little girl in the UK. When we mentioned it to doctors we were immediately shut down and told it was impossible to get in the US.

Any chance of the Mark Cuban Cost Plus Drug Company seeking FDA approval for piracetam and drugs like it?

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Hi Wincy, Sorry to drop my comment here without any scientific evidence or any such certification of experience.

But I had a similar condition in my childhood. Many doctors thought it was some form of complicated asthama or something but couldn't figure out what exactly was it.

Then my parents put me in an breathing camp (yoga retreat kind of thing). I was there for six months and we were convinced there that breathing is life. Breathing is the most important thing in and for life. And slowly, the condition disappeared.

The condition was more of an impediment in the brain blocking the breathing command when I got upset unlike some incurable damage to the lungs. Just teaching and reminding us to breath every second for six months made things a lot better.

If there's no such camp/retreat in your country, you could try India.

You both brought up a memory for the first time where as I child I once decided to hold my breathe and started to panic and worry because I didn't seem to be able to start breathing again. I think it was only a one-time thing, and obviously I started breathing again. I wonder how common it is and what the state of a child who experiences this is - it's fascinating.

Shouldn't we keep piracetam (and the rest of the racetams) away from the FDA? https://nootropicsdepot.com/piracetam-800mg-capsules/

The tyranny of prescription required isn't worth it.

The problem, and the reason they’re out, is because of the FDA. While I agree in principal I wish I didn’t have to search websites for piracetam that are all out of stock due to customs not letting them through.

My own interest in nootropics is some years behind me now, but I note that Nootropics Depot does have bulk phenylpiracetam powder in stock, and I don't recall filling my own capsules to have been especially difficult. Slow and exacting work, to be sure, but also the kind of work that a good podcast or TV show helps go faster. With a little practice and a good capsule filling machine, you can make a month's worth of doses in a couple of hours - cheaper than buying prefilled capsules, too.

Yes, we currently use a powder that I weigh and mix into a solution, and administer the piracetam via feeding tube.

FDA is seizing all piracetam at customs. They haven't moved to the other racetams yet, as far as I know.

From the reddit discussion https://www.reddit.com/r/Nootropics/comments/hkn7v2/piraceta...

Articles like this one are driving their actions. https://jamanetwork.com/journals/jamainternalmedicine/articl...

Stories like this would be a game changer for this new company. I genuinely hope they go for it. In a way, it's surprising that there isn't a charity dedicated to this type of effort for drugs considered safe.

The Wikipedia page [0] says piracetam has been around since the 1950s, and was used to treat epilepsy as early as the 50s. Our daughter’s PEAC [1] is a rare complication of a relatively rare disease.

From my very limited understanding of the regulations, a company would have to spend the million+ dollars it costs to get FDA approval, but then wouldn’t be able to recoup that cost by selling the drug exclusively because the patent has long since expired. The US has this class of drugs that just never got approved and no drug company will ever pay to get approved, even if they are commonplace in other nations.

[0] https://en.m.wikipedia.org/wiki/Piracetam

[1] https://medcraveonline.com/JPNC/peac-prolonged-expiratory-ap...

I had to check if it would fall under Trump's Right to Try Act [0], but sadly it doesn't seem like it would meet the requirements. Perhaps this is something we can continue pushing for more freedom enabling legislation though.

[0] https://www.fda.gov/patients/learn-about-expanded-access-and...

It sounds like we need a mechanism for a company to be granted short term exclusive distribution for drugs that are out of patent but not approved if they sheppard that drug through the approval process.

I believe that's in part what the Orphan Drug Act does - https://en.wikipedia.org/wiki/Orphan_Drug_Act_of_1983

In the short term, how are you getting access to this medicine? Having your friends ship it in from abroad?

I’m hesitant to reveal how as the FDA had been cracking down recently, but racetams are very popular in the nootropics community. It’s sad too because there’s a huge difference between her with this medicine and without.

A few times we’ve missed a day and it’s not a fun experience. Something as innocuous as a diaper change can mean giving her getting upset, turning blue, pulling out the a bag and mask, and giving her oxygen and hoping she’ll come to. Then she’ll sleep for hours. If it’s especially bad, like it was before, she’ll forget words which is super scary.

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