The Berkeley family led the campaign to legalize the first cannabis-derived drug in the United States – Berkeley

By the time he was six, Sam, the son of Evelyn Nussenbaum, video producer of Berkeleyside, was doing dozens of epileptic seizures a day. Nussenbaum and her husband, Fred Vogelstein, discovered that a cannabis drug made in Britain had stopped the convulsions. But they could not use the drug in the United States because it was illegal. Their push to bring the drug to the US has finally been successful. Sam is now 17, and earlier this week, the Food and Drug Administration approved its first cannabis-derived drug. Nussenbaum wrote about the experience of his family.

My son Sam Vogelstein was the pioneer of Epidiolex, the first FDA-approved cannabis drug.

In pioneering, I mean: our family found the drug, convinced his British manufacturer to let us try his launching movement and the way to the United States. It changed everything for us. I hope this will change things for many more patients and, just as important, will lead to a new way of thinking and studying cannabis in this country.

Sam started Epidiolex to treat his seizures in May 2013. He was completely seized. free two and a half years. He has, or has had, epilepsy with myoclonic absence, which caused him up to 100 twitching and jerking convulsions a day. He broke a window with his head; He went to the ground, hard, on a plate of spaghetti;

Seizures began at the age of 4 years. even worse when he was 6 years old. Nothing we did to stop them – not two dozen seizure medications, the ketogenic diet, or the corticosteroids that gave him the moon as a cancer patient. By the time we found our way to Epidiolex, he had had uncontrolled epilepsy for eight years. He interfered with his learning, his game and his social life, and terrorized the whole family

. Many adults with epilepsy smoke cannabis to control their seizures. This is not a secret for neurologists; With one-third of the epileptic population that does not respond to the drugs against epilepsy, patients take things in hand. But children have the same poor crisis control rates as adults and they should not smoke pot; The little we know of the effect of THC on the developing brain suggests that it is not good.

There have been rumors about the anti-epileptic properties of CBD or cannabidiol (another part of the cannabis plant and the active ingredient of Epidiolex). 19th century. But governments have made it almost impossible to study. I learned about this in a 2012 issue of the British medical journal Seizure which had an article on how the compound worked as an anticonvulsant in rodents. It was a ridiculously thin wire to hope for, but we had no other options. There were no other drugs to try and Sam was not a candidate for surgery.

But getting a reliable source was difficult. First, we tried the CBD dyes that we bought locally. But when we tested them in the lab, they all had fewer CBDs than their labels claimed, and some did not have any at all. Then we bought a pot with a science friend who also had a child with epilepsy. She found chemists to extract the CBD and they each gave us what we thought was enough for two weeks. The two children responded, but the two weeks went quickly and the chemists could not risk helping us again.

Then I read about GW Pharmaceuticals in London, a company that was studying the cannabis plant with the permission of the British government. Epilepsy was not their goal then. There was no Epidiolex. But they had greenhouses, their own stock of plants, laboratories, and they regularly and systematically extracted cannabidiol and other cannabis compounds.

It's easy to hate "evil" pharmaceutical companies. I am not pro or con. But they are good at something crucial when you try to treat a misunderstood illness, a threat to life – a quality control. The medicine they manufacture is exactly the same from one batch to the other, from one bottle to the other and one dose to the other. . You do not think how important it is until you can not count on it.

I am not pro or con cannabis either. I have never aspired to treat Sam with any or all of the marijuana plant. I do not quite understand when people congratulate us on treating it with what they consider a natural substance. I am relieved that doctors oversee the administration of this plant compound, isolated from other compounds with which it normally occurs. If I had found a good science that an engine oil extract could help make crises, I would have continued that.

But I sued Dr. Geoffrey Guy instead. And when I finally came to the presidency of GW Pharmaceuticals in the fall of 2012, he was not surprised. While he was developing cannabis-derived medicines for cancer pain and multiple sclerosis, he had read the same studies that I had. When he learned that Sam had answered a CBD extracted in the lab, he was ready to let him try GW; just not in the United States. The anti-cannabis sentiment was too strong here.

But it was legal for us to try it in London under the supervision of a doctor. So we did it during the fifth year Christmas holidays of Sam. And it worked. The day before Sam started GW Pharmaceuticals CBD extract he had 68 seizures. After three days, he had one in one day. We stayed two incredible weeks, most without a crisis. Between several blood tests and Sam EEGs ziplined on London in a park of attractions. We spent a day at the science museum. We rolled the big wheel of London Eye. And then we had to leave. It was not legal in the United States, so GW Pharmaceuticals came to our hotel and collected the rest. I planned to steal it but I got deflated.

Once at home, we submitted requests to the DEA and the FDA to make Sam his own one-boy trial so that he could continue taking the drug. We got approval a few months later, in mid-2013. Inspired by Sam's success on the drug, GW Pharmaceuticals then began extensive testing at UCSF, at the University of New York, Massachusetts General Hospital in Boston, and in about thirty others. hospitals. The company briefly considered naming its SamCan compound, but ended up installing on Epidiolex, a more commercial sound.

Earlier this year, Sam and I traveled to Washington DC to share our experiences with the FDA. About thirty people testified. Sam spoke and was the only person who was applauded. Some parents came to us afterwards and thanked him for speaking on behalf of their children, many of whom were too sick to speak for themselves.

Now that Epidiolex is approved by the FDA, it could be in Walgreens in September. Still on drugs, Sam is 17, six feet tall and will sleep until noon on weekends if allowed to do so. He fences and his coach has just told him that he is ready to start participating in tournaments. He will begin Grade 11 in the fall. He had some minor setbacks, which prompted him to give him a second medication a few years ago, but he has no more epileptic fits. Everything is so normal. Gratitude does not begin to describe how I feel.

Questions remain. Is Sam free of this terrifying disease? Will Epidiolex still work for him? Will insurance companies cover it for him or for someone else once GW Pharmaceuticals has it fixed? Will it cost a fortune? I have no idea.

But I know that I want the legalization of Epidiolex to do more than help stop foreclosures. I want his status as a legal drug to allow scientists to get their hands on cannabis and dismantle it in the lab. With the legal pot for recreation in so many states we should understand it better. Maybe we could quantify when someone is too stoned to drive. It turns out that cannabis high in THC can cause seizures in people who have never had epilepsy. We should know why. Maybe more drugs can be made from cannabis. Maybe there is something that works better than Epidiolex. Maybe not. But it's crazy not to try to find out.