Inquiry after spike in epileptic seizures at Amsterdam Dance Event

DutchNews, October 29, 2018

At least eight people suffered epileptic seizures at the same time during the recent Amsterdam Dance Event, according to organisers who are investigating if stroboscopic lights were partly responsible. 

The incidents happened at around 5.50am on October 19, towards the end of a set by DJ De Sluwe Vos. People who attended the techno dance festival at Amsterdam’s Scheepsbouwloods said they had been left shaken and traumatised by the incident. 

One witness told NOS how her friend had collapsed in front of her on the dance floor. ‘I can still see her coming towards me, in shock. We laid her on the ground in a foetal position. When I looked up, I saw eight groups of people standing round someone who was lying on the ground.’ 

Her friend, aged 18, said she had commented on the unusually bright lights at the event. ‘I said it earlier to a friend. Then at one point I suddenly woke up on the ground.’ 

The woman said she had taken two ecstasy pills during the evening, but had experience of using the drug. ‘I have been to nine techno festivals and never had problems with the lights. It’s not normal for so many people to collapse at the same time.’ 

Increased risk

Organisers admitted the episode was unusual but stressed that none of those who collapsed needed hospital treatment. Festival director Gerke de Groot told NOS enquiries were ongoing to see if a combination of tiredness, drugs and the bright lights had made epileptic seizures more likely. 

‘Brief epileptic attacks have happened before at festivals and dance events. But to have so many so close to each other has never happened to us before,’ he said. 

Esther Croes, spokeswoman for the Trimbos Institute, which specialises in mental health, substance use and addiction issues, confirmed that there was a higher risk of epilepsy associated with dance festivals. ‘An epileptic attack can be triggered by bright, rhythmic light. It’s not just people who are at risk who can be affected, people who are tired or have used drugs also run more risk.’ 

She added: ‘In cases like these it’s always difficult to establish the cause of an epileptic attack. What you can say is that the faster and brighter the lights, the greater the chance of a fit, especially in a darkened room.’ 

De Groot said he wanted to hear from those affected so the festival could investigate whether it needed to take preventive steps in future. Privacy concerns mean that emergency services are unable to disclose many details about the people they treated at the event, such as whether they all took the same drug. 

He added he discussed the incident the next day with the lighting designer and technician. ‘In general we’re not a festival that uses a lot of stroboscopes or lasers, but for this techno festival it was a bit more intense than before.’

Australia cautiously enters medical marijuana market

Yahoo – AFP, Daniel DE CARTERET, July 12, 2017

Recreational marijuana use is illegal in Australia but laws were passed last year
permitting medical use, with a dozen licences since issued for a range of uses
including cultivation and manufacturing (AFP Photo/Saeed KHAN)

Melbourne (AFP) - At a secret location in Australia's southeast, Peter Crook delicately tends to a two-month-old cannabis cutting.

Barely knee high, it is one of about 50 government-sanctioned "mother plants" to be cloned for future generations of crops for the country's fledgling medicinal marijuana industry.

"I think we'll see Australia punch above its weight, both in agriculture research as well as medical technology," says Crook, the chief executive of Cann Group Limited, the firm granted Australia's first commercial grower's licence.

"As different conditions come online we are going to see the market grow rapidly."

Following Canada, Israel, and more than half the US states, who through varying approaches have legalised medicinal marijuana, Australia has signalled its intention for a homegrown industry.

But a patchwork of regulations that guard access for many desperate patients, and a lack of confidence among doctors in prescribing the drug, are acting as impediments.

While recreational marijuana use remains illegal in Australia laws passed last year permit medical use, with a dozen licences since issued, ranging from cultivation and research to manufacturing.

At least 10 sector-related firms have listed on Australia's stock exchange, while tens of millions of dollars has been pledged for clinical trials investigating treatment for conditions including epilepsy and relief for the terminally ill.

Driven by a growing recognition of treatment for chronic pain, arthritis and migraines, the global market is estimated to reach US$55.8 billion by 2025 with the US, Canada and Israel leading the way, US-based analyst Grand View Research says.

'Conservative government'

But unlike those markets, which have liberal patient-access, Australia has a "very conservative government" that wants a regulatory framework in place up front, says Adam Miller, founder of medical cannabis start-up BuddingTech.

"They're doing things by the book so that when they have the evidence required to satisfy not only Australia's but other countries' governments, and medical bodies, they will be able to export those products to those countries," he added.

Last year, researchers at the University of Sydney estimated a legal domestic medical market would initially be worth more than Aus$100 million (US$75 million) a year.

Miller, who was drawn to the industry after researching alternatives for his seriously-ill mother, says unlocking the local market requires easing patient access and educating doctors.

But not at the expense of the pharmaceutical industry's integrity.

"Any new products that are going to be distributed to a large number of patients need to go through the same mechanism that any other drug would go through, and cannabis is no different," he says.

Five-year-old Arielle Harding, who had her first epileptic seizure at 15 months, 

now shows few signs of her condition after her parents started giving her small 

doses of a non-psychoactive marijuana derivative (AFP Photo/Peter PARKS)

Doctors acknowledge the plant's potential in palliative care, epilepsy and spasticity but remain guarded in its broader use, citing limited scientific proof.

"It’s been around since pre-history and if it was the panacea for a whole range of medical conditions it was claimed to be by some advocates, then we would have been using it for a long period of time,” says Australian Medical Association president Michael Gannon.

'Pretty angry pretty quickly'

But for many, change is too slow.

Arielle Harding had her first epileptic seizure at 15-months-old. Suffering from about 100 a day, treatment with traditional drugs made things worse.

Her desperate parents recently tried small doses of Cannabidiol, or CBD, a non-psychoactive marijuana derivative in liquid form and Arielle, now five, shows few signs of her condition.

"At first we were just overjoyed that that had happened but you also find that you get pretty angry pretty quickly, when you realise that we could have had this three years ago and what a difference that would that have made," her father Tim recalls.

The legal CBD oil he purchases is not an elixir, but like thousands seeking cannabis treatment in Australia, Harding says he is unable to explore the drug further for fear of breaking complicated laws.

A 2015 Roy Morgan poll found more than 90 percent of Australians support legalising marijuana for the seriously ill, but advocates say it struggles for recognition because of its "demonised" past.

"It is really important to realise that you can get the medicinal benefits from cannabinoids without necessarily being intoxicated," says Iain McGregor, academic director at the University of Sydney's cannabis research hub.

"We can actually pull apart the intoxicating recreational effects from the therapeutic effects, and again that allows doctors to prescribe with more confidence if it is a non-intoxicating cannabinoid."

As attitudes change, encouraging more research, McGregor is optimistic about the plant's potential "to produce incredible therapeutics for a whole range of diseases that are currently very difficult to treat".

Cannabis extract cuts seizures for epilepsy patients: study

Yahoo – AFP, May 24, 2017

Cannabidiol, or CBD, is derived from cannabis plants, but does not cause users
 to get high The company procudes high cannabidiol (CBD) content cannabis
with THC (psychoactive component) content below the Swiss legal limit.
KannaSwiss sell medicinal oil and flowers to smoke. (AFP Photo/Fabrice COFFRINI)

Miami (AFP) - The first large-scale clinical trial of a cannabis derivative known as cannabidiol shows it was able to cut the frequency of severe epileptic seizures by 39 percent, researchers said Wednesday.

Cannabidiol, or CBD, is derived from cannabis plants, but does not cause users to get high.

The study in the New England Journal of Medicine comes after years of anecdotal evidence of cannabidiol's effects.

It focused on young patients with Dravet syndrome, a rare form of epilepsy.

"Cannabidiol should not be viewed as a panacea for epilepsy, but for patients with especially severe forms who have not responded to numerous medications, these results provide hope that we may soon have another treatment option," said lead investigator Orrin Devinsky, professor of neurology, neurosurgery, and psychiatry at New York University Langone Medical Center.

"We still need more research, but this new trial provides more evidence than we have ever had of cannabidiol's effectiveness as a medication for treatment-resistant epilepsy."

Researchers used an experimental liquid form of CBD, called Epidiolex, which is manufactured by GW Pharmaceuticals.

It has not been approved for use by the US Food and Drug Administration.

A total of 120 children and adolescents, aged two to 18, with Dravet Syndrome were randomized to receive either a placebo or CBD, in addition to their usual treatment.

The trial took place at 23 sites in the United States and Europe over the course of 14 weeks.

"Seizure frequency dropped in the CBD-treated group by 39 percent from a median of nearly 12 convulsive seizures per month before the study to about six," said the study.

"Three patients' seizures stopped entirely."

The placebo group saw a much smaller 13 percent reduction in seizures.

Most patients reported side effects, most commonly vomiting, fatigue and fever.

A total of 93.4 percent of patients in the CBD group and 74.6 percent of those treated with placebo experienced side effects, which were generally reported as mild or moderate.

But eight patients in the CBD group withdrew from the trial because of side effects, compared to one participant in the placebo group.

Epilepsy drug behind up to 4,100 'severe birth defects' in France

Yahoo – AFP, Brigitte CASTELNAU, April 20, 2017

From 1967 to 2016, between 64,100 and 100,000 pregnancies in France were
exposed to valproate, resulting in 41,200 to 75,300 live births, according to the
report (AFP Photo/PHILIPPE HUGUEN)

Paris (AFP) - The epilepsy medication valproate is responsible for "severe malformations" in 2,150 to 4,100 children in France since the drug was first marketed in the country in 1967, according to a preliminary study by French health authorities.

Women who took the drug during pregnancy to treat epilepsy were four times more likely to give birth to babies with congenital malformations, said the report, jointly issued by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration.

"The study confirms the highly teratogenic" -- that is, capable of causing birth defects --- "nature of valproate," said Mahmoud Zureik, scientific director of ANSM and a co-author of the report.

"The figure of about 3,000 severe malformations is very high," he told AFP.

The types of birth defects attributed to the drug included spina bifida -- a condition in which the spinal cord does not form properly, and can protrude through the skin -- as well as defects of the heart and genital organs.

The risk of autism and developmental problems was also found to be higher, and will be quantified in a follow-up report later this year.

An earlier estimate suggested that 30 to 40 percent of children exposed in the womb could suffer such disorders.

Risks known since 1980s

From 1967 to 2016, between 64,100 and 100,000 pregnancies in France were exposed to valproate, resulting in 41,200 to 75,300 live births, according to the report.

The vast majority of the birth defects occurred for women under treatment for epilepsy.

But starting in the late 1970s, valproate -- marketed around the world as Depakine, Depakote, Stavzor and other trade names -- was also prescribed in France to treat bi-polar disorder.

Bi-polar women taking the drug were twice as likely to give birth to children with major birth defects, the study found.

The lower risk compared with women treated for epilepsy probably stems from the fact that -- for pregnant bi-polar women -- doctors stopped prescribing valproate early in the pregnancy, Zureik said.

"The risk of severe malformation is limited to the first two trimesters of pregnancy," said Alain Weill, a researcher at the French health insurance administration and a co-author of the report.

The risk of birth defects associated with valproate has been known since the 1980s, especially for spina bifida, which occurs 20 times more frequently in foetuses exposed to the medication.

But the drug can still be prescribed to pregnant women when all other forms of treatment for epilepsy fail. That ruling, however, was put in place only in 2015.

Valproate is sold in France under the brand name Depakine by pharmaceutical giant Sanofi, but is also available in generic forms.

Inadequate warnings?

Some French families of children with birth defects born to women who took the drug while pregnant -- grouped under an umbrella association called APESAC -- have sued the company, claiming that it did not adequately warn about the risks.

"The number of victims is potentially huge," said APESAC president Marine Martin, who says two of her children -- a girl and a boy -- suffered physical defects brought on by valproate.

"We need to take into account children with malformations and autism, as well as families that lost a baby due to treatment during pregnancy," she told AFP.

Her association estimates a total of 30,000 to 50,000 victims -- children and families included.

Gerard Bapt, a deputy in France's national assembly and a board member of ANSM, welcomed the report.

"It now appears fundamental that valproate in all its forms should not be prescribed for women of child-bearing age," he said in a statement. Medically necessary exceptions, he added, should be rare and accompanied by "mandatory contraceptive use".

In a statement, Sanofi said it had been "totally transparent with health authorities."

"We are aware of the painful situation confronting the families of children showing difficulties that may have a link with the anti-epileptic treatment of their mother during pregnancy," the drugmaker said.

France was last hit by a major drug scandal in 2010, when it was revealed that the off-label use of a diabetes drug called Mediator for weight-loss could cause fatal heart problems.

The legal fallout from that episode is still unfolding.

Colombia legalizes medical marijuana

Yahoo – AFP, Paula Carrillo, December 22, 2015

Ines Cano (R) and her daughter Luna Valentina, who uses medical marijuana
 to treat the symptoms of refractory epilepsy, visit the Cannalivio cannabis lab
near Medellin, Colombia on May 7, 2015 (AFP Photo/Raul Arboleda)

Bogota (AFP) - Colombian President Juan Manuel Santos signed a decree Tuesday legalizing and regulating medical marijuana, the latest softening of the country's hardline tactics in the war on drugs.

In a nationally televised address, Santos announced it would be fully legal to grow, process, import and export cannabis and its derivatives for medical and scientific use.

"This decree allows licenses to be granted for the possession of seeds, cannabis plants and marijuana," he said from the presidential palace.

"It places Colombia in the group of countries that are at the forefront... in the use of natural resources to fight disease."

He added that the measure "does not go against our international commitments on drug control."

Colombia's government has long been a close ally of the United States in fighting international drug trafficking, using its military and billions of dollars in US funding to try to shed its title as the world's largest cocaine producer.

But it has shown signs of easing its hardline stance in recent months.

Santos's announcement follows a recent decision to stop aerially spraying the herbicide glyphosate on fields of coca, the raw ingredient for cocaine.

The World Health Organization warned in April that the chemical, sold by US biotech company Monsanto under the brand name Roundup, is "probably carcinogenic."

Santos also announced in September that Colombia would begin giving land to farmers who stop growing coca.

Medical marijuana had previously fallen into a legal gray area in Colombia.

It was authorized under a 1986 law, but the lack of regulation prevented production on a national level.

"The manufacture, export, sale, and medical and scientific use of this and other substances have been permitted for several decades in Colombia. However, they were never regulated. That is what we are doing today," Santos said.

Ines Cano administers medical marijuana to her daughter Luna Valentina (L)

 at their home in Medellin on November 25, 2015; Valentina, 12, was born with 

refractory epilepsy and uses cannabis to calm her seizures (AFP Photo/Raul Arboleda)

Under the decree, growers will apply for licenses from the National Narcotics Council, while those seeking to manufacture cannabis-based drugs will apply for permits from the health ministry.

The health ministry will also grant permits to export such drugs to countries where they are legal.

"Our goal is for patients to be able to access medications made in Colombia that are safe, high-quality and accessible. It is also an opportunity to promote scientific research in our country," Santos said.

'Plan Colombia'

Colombia decriminalized possession of up to 20 grams of marijuana in 2012, and it is legal to grow up to 20 cannabis plants. But consuming it in public and selling it are illegal.

Colombia's Congress is currently debating a separate medical marijuana bill that would define crop limits and other production details.

Its sponsor, Senator Juan Manuel Galan, told AFP he hopes to have it signed into law by June.

Medical marijuana is already used in Colombia on a small scale.

For example, some epileptics use cannabis extract to control their seizures.

But health professionals and pharmaceutical companies say the new decree will make it much easier to buy, sell and manufacture such drugs.

Illegal drugs have given rise to horrific violence by drug cartels in Colombia, and have fueled a five-decade conflict between leftist guerrillas and the Colombian government that has killed more than 220,000 people.

The country has received $9 billion in US funding since 1999 under "Plan Colombia," a military and economic cooperation program aimed at combating drug trafficking.

But it remains a top producer of illegal drugs, particularly cocaine.

Coca cultivation surged by 44 percent last year, to 69,000 hectares (170,000 acres), according to the United Nations.

Epilepsy kids given cannabis

The West Australian, Cathy O'Leary Medical Editor, November 4, 2013

Medical cannabis: Used to treat severe
epilepsy. Picture: AP

Desperate WA families are resorting to giving their children medical cannabis in a bid to stop dangerous epileptic seizures.

More parents are obtaining free cannabis tincture from home-based manufacturers in the Eastern States after exhausting conventional treatment for their children's severe epilepsy.

The main psychoactive ingredient in cannabis, tetrahydrocannabinol, is removed from the serum so there is no "high".

Supporters say it can cut the rate of seizures with minimal side effects.

Epilepsy Association of WA chief executive Suresh Rajan said he could not endorse the controversial treatment but there seemed to be a groundswell of interest among WA families.

"Anecdotally, there are more mums emailing and talking to me about the fact that they are considering the issue," he said. "Parents are certainly researching the issue for themselves on the internet and then bringing it to my attention to almost seek endorsement."

Mr Rajan said interest seemed to have been triggered by several high-profile cases overseas, including that of six-year-old Charlotte Tigi, from Colorado, who reportedly had a dramatic improvement in her epilepsy after using medical cannabis.

Several Perth women spoke to _The West Australian _, on the condition of anonymity, after trying medical cannabis on their children. A mother of a five-year-old girl said she had been taking the tincture for a week, alongside her normal medication, and the results were promising.

"The day after she started on it she had the best day at school and was able to do all the activities," the woman said. "The teachers all commented on how much better she seemed."

Another woman said her young adult son was using the serum to see if it could help.

The medical use of cannabis is not permitted in Australia except in special circumstances.

Royal Perth Hospital neurologist John Dunne said there was some evidence that cannabinoid preparations could have an anti-epileptic effect, but research was limited because of the illegality of the products and inability to patent them.

In some cases, the preparation could make the epilepsy worse.